Bio Screening Industry News

(RTTNews) - True to expectations, Jeffrey Kindler, the CEO of Pfizer Inc. (PFE | Quote | %20%20%20%20%20%20PFE%20|%20%20%20%20%20%20%20Quote%20|%20%20%20%20%20%20%20Chart%20|%20%20%20%20%20%20%20News%20|%20%20%20%20%20%20%20PowerRating“);”>Chart | News | PowerRating), scripted a new playbook for the drug giant in 2009, accelerating the process of transformation by clinching the largest pharmaceutical deal in nearly a decade.

The acquisition of Wyeth for $68 billion earlier this year represents a major move by Pfizer to plug the impending holes in its balance sheet when patents covering some of its key drugs expire in the next few years. Between 2010 and 2012, drugs that make up 42% of Pfizer’s pharmaceutical revenue, are slated to lose patent protection.

Let’s take a look at some of the Pfizer news that made headlines this year.

The Mega Deal

Though Pfizer is not new to mega deals, Kindler was dubious of such mega mergers till last year. He preferred only bolt-on or product acquisitions to major acquisitions. However, the craving for new sources of revenue and the inability of the company’s near-term pipeline to make up the slack when its blockbusters lose patent exclusivity made Kindler adopt the mega-merger strategy this year and acquire Wyeth.

Wyeth has a promising pipeline as well as a number of blockbusters in its arsenal, including rheumatoid arthritis drug Enbrel, jointly marketed with Amgen (AMGN | Quote | Chart | News | PowerRating), pneumonia vaccine Prevnar, antidepressant Effexor, nutritional products, intravenous antibiotic Zosyn and the hormone replacement therapy Premarin family of drugs. Enbrel topped $3 billion in total sales, Effexor raked in worldwide revenue of $3.93 billion, while Prevnar notched up sales of $2.72 billion in 2008.

As mentioned above, drugs that make up 42% of Pfizer’s pharmaceutical revenue, are slated to lose patent protection between 2010 and 2012. The drugs going off-patent include Aricept, Lipitor, Viagra, Detrol, Geodon and Xalatan. Lipitor alone accounted for 28% of Pfizer’s pharmaceutical sales last year.

Pfizer’s revenue in 2008 was $48.3 billion, while Wyeth’s revenue for the year totaled $22.8 billion. With highly complementary businesses, the combined company has a diverse product portfolio that includes 17 products with more than $1 billion each in annual revenue. It is expected that no drug will account for more than 10% of the combined company’s revenue in 2012.

The combination also brings together a robust pipeline of biopharmaceutical research and development projects, including programs in diabetes, inflammation/immunology, oncology and pain, as well as significant opportunities in Wyeth’s Alzheimer’s disease pipeline.

Pfizer completed the acquisition of Wyeth in October, nine months after the companies inked a definitive merger agreement. The acquisition is expected to be accretive to Pfizer’s adjusted earnings per share in the second full year after closing and yield cost savings of about $4 billion to be fully realized by the third year after closing.

No doubt, the acquisition of Wyeth will provide a more diversified portfolio and alleviate Pfizer’s sales decline, but this will not be the panacea for the threat caused by the raft of patent expirations, according to research firm Datamonitor. Wyeth also faces looming patent expiration on its key drug Effexor XR. The depression drug, which notched up $3.93 billion in sales last year, is slated to lose patent exclusivity in 2010.

However, as the company gets rid of operational overlap, the deep cost cuts will see the combined company delivering profit growth.

For 2009, Pfizer now expects reported earnings to range between $1.45 and $1.50 per share and adjusted earnings to range between $2.00 and $2.05 per share. Previously, the company was anticipating reported earnings to range between $1.30 and $1.45 per share and adjusted earnings to range between $1.90 and $2.00 per share. The company now expects reported revenues in the range of $49 billion-$50 billion, up from its prior forecast of $45 billion-$46 billion. The revised guidance reflects the completion of the Wyeth transaction.

Cost-cutting measures in full gear

Pfizer has been in restructuring mode since 2005 and has retained its focus on cutting costs, including outsourcing and offshoring to ease the pressure on its topline.

Since 2005, Pfizer has significantly reduced its workforce. According to the company’s quarterly filing with the SEC, from June 2005 through September 27, 2009, it terminated 26,300 of its employees and has expensed employee termination costs of $5.35 billion.

In tandem with its merger with Wyeth, Pfizer is in the process of laying off 15% of the combined company’s workforce. That includes the 10% workforce reduction announced earlier this year. In the first nine months of 2009, the company reduced its workforce by approximately 6,500 employees. The company’s aggressive belt-tightening measures are expected to generate significant cost reductions for the combined company.

Pfizer anticipates achieving total annual cost savings of about $6 billion by the end of 2012. The targeted savings include $2 billion in net cost reductions from Pfizer cost-reduction initiatives, of which about $950 million has been achieved through September 27, 2009, and an additional $4 billion in expected synergies related to the integration of Wyeth.

The Neurontin Controversy

There are about 1,200 lawsuits over Pfizer’s off-label marketing of Neurontin. While the drug was originally approved by the FDA as an add-on treatment for partial epileptic seizures in 1993 and for the management of post-herpetic neuralgia in 2002, Pfizer has been marketing it to treat multiple conditions including mood swings and arthritis. In 2004, Pfizer paid $430 million in fine to settle civil and criminal charges of promoting Neurontin for unapproved uses.

The first lawsuit against Pfizer, in regard to Neurontin came to trial in July of this year. The suit was filed by the family of Susan Bulger, a 39-year-old woman who committed suicide in 2004. Bulger had been prescribed Neurontin for arthritis, an off-label use, and was taking the drug for two years. However, after just one day of testimony, Bulger’s family dropped the case against Pfizer after an anonymous donor offered to set up a trust for the deceased woman’s 10-year old daughter.

A review of Neurontin trial results published by Kay Dickersin last month in the New England Journal of Medicine, accuses Pfizer of manipulating the trial data for various unapproved indications. The author Kay Dickersin was an expert witness in the trial. Pfizer, which has disputed the findings of the article, said the review published in the journal was “derived from a report created for litigation and coauthored by plaintiffs’ expert witness, who was hired to produce opinions to support plaintiffs’ arguments.”

Though the first case involving Neurontin has been dismissed, this legal tangle is far from over. However, Pfizer firmly believes that there is no scientific evidence to prove that Neurontin causes suicidal behavior.

The basic U.S. patents relating to Neurontin expired in 1994 and 2000. However, in April 2000, a U.S. patent was granted relating to stable pharmaceutical compositions of Neurontin containing low levels of lactam impurity. This patent expires in 2017.

Neurontin, which once fetched $2 billion in sales for Pfizer, began to face generic competition in the U.S. in the latter half of 2004. Subsequently, the pharma giant launched its own generic version of Neurontin in the U.S. through its Greenstone Ltd. generic pharmaceutical subsidiary. In 2008, the global sales of Neurontin totaled $387 million, a decline of 10% from 2007. For the nine months ended September 2009, Neurontin sales declined 18% to $242 million from the comparable period a year before.

Major legal settlements

Pfizer, which is no stranger to legal tussles, got itself cleared of some of the legal issues this year by settling with the plaintiffs. After all, legal beagle Kindler knows that closure of significant legal matters will only help his company to enhance its focus on discovering, developing and delivering innovative medicines.

On July 30, Pfizer settled the long drawn-out lawsuit with Kano State government in Nigeria related to the company’s 1996 study of antibiotic drug Trovan.

The suit filed by authorities in Kano accused Pfizer of administering the untested and unapproved antibiotic called Trovan to children during a meningitis epidemic in 1996, resulting in the deaths of an unspecified number of children and leaving others deaf, paralyzed, blind or brain-damaged.

According to the lawsuit, Pfizer did not obtain consent from the children’s families before enrolling the children in the ill-fated trial. The suit also accused Pfizer of conducting the study of Trovan despite knowing the life-threatening side effects of the drug and being well aware that it was unfit for human use. However, Pfizer has denied any wrongdoing or liability in connection with the 1996 study.

Under the terms of the settlement, Pfizer agreed to pay $30 million over a period of two years to support health initiatives designated by Kano State and to reimburse Kano State for $10 million in legal costs associated with the litigation.

Pfizer has also agreed to establish a Healthcare/Meningitis Fund from which study participants can receive financial support. The maximum amount that could be disbursed by the Fund is $35 million, but the final amount will depend on the total number of valid claims submitted.

In turn, Kano State agreed to dismiss both the civil and criminal Trovan-related cases it filed against Pfizer and various individuals.

Yet another lawsuit that Pfizer resolved this year is a multi-billion dollar settlement and the largest healthcare fraud settlement in the history of the Department of Justice. Pleading guilty to a felony crime in off-label promotional practices for painkiller Bextra, which was withdrawn from the market in 2005 over safety concerns, and fraudulent marketing of anti-psychotic drug Geodon, antibiotic Zyvox and anti-epileptic drug Lyrica, Pfizer on September 2 announced it agreed to pay $2.3 billion in fines to settle federal criminal and civil charges against it. The fine was already factored into the fourth-quarter earnings of 2008 and no additional charges are expected to be carried over.

In October, the drug giant entered into an agreement with drugmaker Mylan Inc. (MYL | Quote | Chart | News | PowerRating) related to a generic version of Vfend (voriconazole), an antifungal agent. In the same month last year, Matrix Laboratories Ltd., the India-based subsidiary of Mylan, challenged Pfizer’s patents for its Vfend tablets, 50 mg and 200 mg, with the filing of its Abbreviated New Drug Application.

However, Pfizer did not file a lawsuit against Matrix within the statutory 45-day time period. Now that Pfizer has entered into an agreement with Mylan, the generic drugmaker will have the right to market voriconazole tablets in the U.S. in the first quarter of 2011. The details of the agreement with Mylan were not disclosed. Vfend logged in sales of $743 million in 2008 and $555 million for the nine months ended September 2009.

Not out of legal woods…

Though Pfizer has settled some of its long-standing legal issues, it is not completely out of the legal woods. In addition to its own legal hassles, Pfizer also has to resolve Wyeth’s legal woes inherited through the acquisition.

Wyeth’s hormone replacement therapy drugs, Premarin and Prempro touted as “magic bullets” are indicated for the relief of hot flashes and night sweats, associated with menopause. After the U.S. government’s Women’s Health Initiative study found that healthy postmenopausal women enrolled in the study who were treated with the hormone replacement therapy drugs, Premarin and Prempro had increased risk of invasive breast cancer, stroke and blood clots, Wyeth came under fire. The study, which was to continue until 2005, came to an abrupt halt in early June 2002. However, the drugs continue to be in the market.

Wyeth faces lawsuits from more than 10,000 women who claim that the company’s hormone-replacement therapy drugs Premarin and Prempro caused breast cancer.

In the trial related to hormone-replacement therapy drugs, two verdicts were announced this year, and Wyeth, now a division of Pfizer, has been ordered to pay $103 million in punitive damages in the two cases.

Wyeth has not set aside any legal reserve for dealing with the hormone replacement therapy litigation and settlements.

Regulatory Approvals

Pfizer spends more than $7 billion annually on research and development. Last year, the company abandoned its research projects related to heart disease, obesity and bone health to focus on lucrative fields like cancer and Alzheimer’s.

According to the company’s latest pipeline update, the areas of focus include allergy & respiratory; cardiovascular, metabolic and endocrine diseases; gastrointestinal; genitourinary; infectious diseases; inflammation; neuroscience; oncology; ophthalmology and pain.

The following are few of Pfizer’s drugs that won regulatory approval this year.

A Double Treat

It was a double treat from the FDA for Pfizer on November 20, as the drug giant won approval for two of its drugs the same day.

Pfizer’s antipsychotic Geodon won expanded FDA approval for maintenance treatment of bipolar I disorder as an adjunct to lithium or valproate in adults.

The drug is already FDA-approved as a monotherapy in the treatment of acute manic and mixed episodes associated with bipolar disorder, with or without psychotic features, and for the treatment of schizophrenia.

Since the FDA approval of Geodon in February 2001, nearly 2 million adult patients have been treated with this drug. Unlike other antipsychotics, Geodon is not associated with weight gain. The drug raked in global sales of $1 billion last year and $713 million for the nine months ended September 30, 2009.

Pfizer also received FDA approval for the intravenous formulation of Revatio for the continued treatment of patients with pulmonary arterial hypertension who are currently prescribed Revatio Tablets but who are temporarily unable to take oral medication.

Pulmonary arterial hypertension is a rare, progressive disease that affects an estimated 100,000 men and women worldwide. This incurable disease is characterized by continuous high blood pressure in the pulmonary arteries, often leading to heart failure and premature death.

Revatio Tablets were approved by the FDA in June 2005 and by the European Medicines Agency, or EMEA, in November 2005. Revatio contains the same active ingredient as Viagra, which is used to treat erectile dysfunction (impotence). Pfizer doesn’t break out Revatio sales when reporting its quarterly results, so there are no specific numbers on the drug’s sales.

The first canine cancer drug

All these years, veterinarians had to rely on human oncology drugs without knowledge of how safe or effective they would be for dogs. Cancer treatments used in animals are used in an “extra-label” manner as allowed by the Animal Medicinal Drug Use Clarification Act of 1994. However, dog owners, in consultation with their veterinarian, now have an option for treatment of their dog’s cancer.

On June 3, the FDA approved Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs. According to the Morris Animal Foundation, which is dedicated to funding animal health research, 1 in 4 dogs die of cancer. About 1.2 million new canine cancer cases are reported in the U.S. every year. The product is expected to be available for purchase in early 2010.

U.K.’s NICE becomes nice to Sutent

Reversing its earlier stance, the United Kingdom’s NICE (National Institute for Health and Clinical Excellence), which evaluates the cost-effectiveness of medications, recommended reimbursement for kidney cancer drug Sutent as a second-line treatment for patients with advanced gastrointestinal stromal tumor.

The decision of NICE gives hope to patients with gastrointestinal stromal tumors who develop resistance to Imatinib (Novartis’ (NVS) Gleevec), according to Pfizer. It is estimated that about 7,000 people in the U.K. are diagnosed with kidney cancer every year and that 3,600 patients are eligible to receive Sutent since they have an advanced form of the disease.

Last year, NICE rejected four kidney cancer drugs including Sutent for the treatment of advanced and/or metastatic forms of renal cell carcinoma within the National Health Service due to financial considerations.

In international markets, the sales growth of Sutent continues to outpace its growth in the U.S. In 2008, Sutent’s annual sales in the U.S. were up a mere 7% to $254 million, while international sales of the drug rose 72% to $593 million. In the third-quarter ended September 30, 2009 Sutent generated U.S. sales of $192 million, an increase of 2% over the comparable quarter last year, while international sales of the drug totaled $479 million, an increase of 9% over the year-ago quarter.

Old Drug, New use

Pfizer remains committed to expand its HIV drug Selzentry’s current indications. The company is seeking approval of Selzentry in treatment of adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

In October, an FDA panel recommended the expanded use of Selzentry in treatment-naïve patients. The FDA is scheduled to make a final decision in the coming months.

Selzentry was granted accelerated approval in August 2007 and full approval in November 2008 by the FDA for use in patients with resistant HIV strains or who do not respond favorably to multiple antiretrovirals.

According to AIDS Healthcare Foundation, Selzentry’s price has increased 10% since its approval in 2007 two years ago to $13,767 per-patient per year. If approved for the expanded use, Selzentry would become the most-expensive first-line AIDS drug.

A shot at vaccines

For Pfizer, vaccine innovation is a key strategic priority and an expression of its vision to broaden and diversify its global product portfolio.

On November 18, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 10 to 1 recommending Prevnar 13 for the prevention of invasive pneumococcal disease in infants and young children. The FDA is scheduled to make a final decision on Prevnar 13 on December 30, 2009.

In late September, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Prevenar 13. A final decision is expected by European regulatory authorities in December. Additionally, the vaccine is being studied in global phase-III clinical trials for the prevention of pneumococcal disease in adults, with regulatory submissions expected in 2010.

Prevnar 13 targets thirteen strains of bacteria known as streptococcus pneumoniae, while Prevnar, which has been in the market since 2000, targets only seven strains of bacteria. Prevnar is Wyeth’s second top-selling drug and had global sales of about $2.7 billion last year.

Clinical Trial Missteps and Regulatory Knockdowns

This year, the pharma behemoth endured failure in a number of late-stage trials, raising concerns about its R&D department.

Jan.30 - Pfizer halted a phase III study of its investigational agent axitinib for the treatment of advanced pancreatic cancer following no evidence of improvement in the primary endpoint of survival in patients treated with axitinib and gemcitabine compared to gemcitabine alone. However, the company is investigating axitinib in renal cell carcinoma where it is currently in a late-stage testing for second-line treatment.

Feb.24 - Two late-stage development programs for investigational compounds esreboxetine for fibromyalgia and PD 332,334 for generalized anxiety disorder were terminated as neither was found to be better than the current standard of care. Pfizer already has an FDA-approved medicine for the treatment of fibromyalgia sold under the brand name Lyrica. The company plans to pursue expanded indication for Lyrica in the treatment of generalized anxiety disorder, a condition that overlaps with fibromyalgia.

April 2 - Pfizer’s phase III program of Sutent suffered its first blow of the year when a trial evaluating the drug for breast cancer indication had to be halted. The trial dubbed SUN 1107 evaluated single-agent Sutent versus single-agent capecitabine for the treatment of a broad range of patients with advanced breast cancer after failure of standard treatment. An independent Data Monitoring Committee found that Sutent would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival.

June 1 - The phase III program of Sutent suffered yet another blow when the company had to halt a trial dubbed SUN 1094 that evaluated Sutent plus paclitaxel versus bevacizumab plus paclitaxel for the first line treatment of patients with advanced breast cancer. The independent Data Monitoring Committee found that treatment with Sutent in combination with paclitaxel would be unable to meet the primary endpoint of superior progression-free survival (PFS | Quote | Chart | News | PowerRating) compared to the combination of bevacizumab and paclitaxel. No new safety issues were identified.

June 30 - Another late-stage trial of Sutent to bite the dust was that of the metastatic colorectal cancer study. The trial dubbed SUN 1122 evaluated Sutent plus chemotherapy drug combination FOLFIRI versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer. The independent Data Monitoring Committee found that the addition of Sutent to the chemotherapy regimen FOLFIRI would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival compared to FOLFIRI alone.

Oct.9 - Following recommendations of an independent safety monitoring committee, Pfizer temporarily stopped enrolling new patients in a late-stage trial dubbed Advigo 1016 that was evaluating its experimental lung-cancer compound Figitumumab. The primary objective of the trial is to determine whether the addition of Figitumumab in combination with paclitaxel and carboplatin prolonged survival in patients with non-small cell lung cancer.

An independent safety monitoring committee overseeing the study found more serious adverse events, “including fatalities, in patients who were randomized to receive figitumumab,” than in patients who didn’t receive the investigational drug. Figitumumab, with estimated sales potential of $400 million to $1.2 billion by 2015, was one of the drugs that Pfizer had been counting on to replace sales of Lipitor when it loses basic patent protection in the U.S. in March 2010. The second patent covering the calcium salt of atorvastatin, the active ingredient in Lipitor, expires in June 2011.

However, another late-stage lung cancer study testing Figitumumab in combination with Roche Holding Ltd.’s (RHHBY.PK) and OSI Pharmaceuticals Inc.’s (OSIP | Quote | Chart | News | PowerRating) Tarceva is continuing to enroll new patients, according to Pfizer.

Third time’s no charm for Fablyn

On January 16, the FDA issued a complete response letter for Pfizer’s investigational osteoporosis drug Fablyn (lasofoxifene) and sought additional information.

Last September, an FDA panel voted 9 to 3, endorsing Fabyln. Though study results of Fabyln have demonstrated its efficacy in treating osteoporosis in postmenopausal women, according to the FDA Administration advisory board briefing document, Fabyln increased the chances of cancer or stroke-related deaths. Other side effects include blood clots.

Fablyn, a selective estrogen receptor modulator, or SERM, was developed by Pfizer with the help of screening technology licensed from Ligand Pharmaceuticals Inc. (LGND | Quote | Chart | News | PowerRating).

It was Fablyn’s third go-around with the FDA. The FDA rejected Fablyn as a medicine for the prevention of post-menopausal osteoporosis in September 2005 and for the treatment of vaginal atrophy in January 2006 on concerns that the drug may lead to cancer in the lining of the uterus.

However, the drug received approval from the European Commission in March of this year for the treatment of osteoporosis in post-menopausal women at increased risk of fracture.

Late-stage pipeline

Pfizer has more than twenty phase III programs and Wyeth has more than five late-stage trials that are currently underway.

Wyeth is also conducting a late-stage trial evaluating Pristiq for the non-hormonal treatment of vasomotor symptoms associated with menopause. The FDA, which issued an approvable letter for Pristiq in July 2007, has sought additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq for the treatment of menopausal symptoms. The requested clinical trial that is underway is expected to be completed in the first half of 2010.

In the first half of 2009, Mexico and Thailand granted approvals for Pristiq for the treatment of menopausal symptoms.

Viviant is yet another Wyeth drug waiting to pass muster with the FDA. The investigational postmenopausal osteoporosis pill has been twice at the FDA altar - in December 2007 and May 2008 - only to be turned down. In its approvable letters, the regulatory agency had requested further analyses and discussion concerning the incidence of stroke and venous thrombotic events and requested additional source documents related to Viviant.

In a recent SEC filing, Wyeth said the FDA will be convening an advisory committee to review its pending New Drug Application for Viviant. Wyeth expects the FDA-requested advisory committee meeting will be scheduled following submission of its complete response to the approvable letters, which are planned for filing later this year.

The EU trade name for Viviant is Conbriza and the drug was approved for the treatment of postmenopausal osteoporosis in women at increased risk of fracture in April of this year. The drug is expected to hit the pharmacy shelves in the EU next year.

In July, Wyeth announced new positive results from a late-stage trial of Aprela, a drug under development for menopausal symptoms and osteoporosis. An initial NDA for Aprela is expected to be filed no earlier than the first half of 2010.

In December, Pfizer made an entry into the market for orphan drugs by acquiring worldwide rights to Uplyso, an experimental drug for Gaucher’s disease, a rare genetic disorder, from Israeli biotech firm Protalix BioTherapeutics Inc. (PLX | Quote | Chart | News | PowerRating). The current standard of care for Gaucher patients is enzyme replacement therapy and Genzyme Inc. (GNZ | Quote | Chart | News | PowerRating)’s Cerezyme is currently the only approved enzyme replacement therapy for Gaucher disease. Last year, Cerezyme fetched $1.2 billion in sales for Genzyme. Protalix is close to complete a rolling New Drug Application submission for Uplyso with the FDA. The product is expected to reach the market next year.

Eyeing generic drug pie

It is no secret that Pfizer has been vying for a greater share of the generic drug market. The drug giant estimates that the global generic business is set to grow to $500 billion by 2012 from $270 billion in 2006.

Early last year, the company formed an Established Products Business Unit to execute growth strategies tailored to the unique needs of branded emerging markets (such as China, India, Brazil and Russia), branded traditional markets (such as Japan, Western Europe and South Korea), and intellectual-property-driven markets (such as the United States and Canada).

Pfizer’s global annual sales of established products are approximately $10 billion. (Established products are medicines that have lost or will soon lose patent protection).

In May, Pfizer entered into agreements with India-based Claris Lifesciences Ltd. to commercialize 15 sterile injectable medicines after the products are no longer patent protected and have lost market exclusivity in North America, Europe, Australia and New Zealand.

The same month, Pfizer expanded its agreements with Aurobindo Pharma Ltd. in India by acquiring rights to 55 solid oral dose products and 5 sterile injectable products for patients in more than 70 emerging market countries.

Closing Thoughts

Shares of Pfizer, which touched a 12-1/2 year intra-day low of $11.62 in March, have since recovered nearly 55% and currently trade around $18. As the now streamlined, more flexible and strategically grounded Pfizer gets ready to face another new year, will there be a change in investors’ ho-hum attitude towards the stock?

For comments and feedback: contact editorial@rttnews.com
Copyright(c) 2009 RTTNews.com, Inc. All Rights Reserved

Source: tradingmarkets.com

Forma Therapeutics has closed on a Series B financing that raised a total of $25.5 million. The round was led by new investor Lilly Ventures. Lilly was joined by existing investors Novartis Option Fund and Bio*One Capital of Singapore. Lexington-based Cubist Pharmaceutical, Inc. also joined as a new equity investor through a conversion of a previously issued note.

Steve Hall, a venture partner at Lilly Ventures, will join Forma’s board of directors. The Cambridge-based company has a drug discovery technology platform designed to help develop new drug targets for cancer and other diseases.

“With this new funding, Forma will focus on advancing our internal target-based oncology programs and in parallel, we will continue to pursue non-dilutive collaborations to further build our integrated drug discovery platform,” said Steven Tregay, CEO of Forma, in a statement.

More about Forma Therapeutics
Forma, which was founded in May of 2007, first announced a $25 million dollar series A financing round in January of 2009, followed a week later by a $200 million deal with the Novartis Option Fund, which gave the company its first $4 million in funding to launch.

Also in January, Forma entered a three-year collaboration agreement with Cubist Pharmaceuticals Inc. in which Cubist developed antibacterial compounds discovered by Forma. The deal calls for Forma to receive $14 million in upfront payments, delivery and research funding and equity; If Cubist pursues commercialization of the compounds, the deal could garner Forma another $54 million in milestones and royalties.

In July, Forma formed partnerships with The Leukemia & Lymphoma Society to move the health agency’s research products toward development quickly, and with Novartis AG to use Forma’s cell-based screening platform to discover inhibitors for undisclosed protein-protein interaction targets to help develop cancer drugs.

Source: masshightech.com

Specialty antimicrobial research and development company Syntopix (AIM: SYN) took another step closer to commercialising a new product targeting a large consumer healthcare market, reporting good results from the trials of its new compound for the treatment of acneic skin, a condition that affects 85% of the population during their lifetime.

Over the course of the trials, formulations using the Syntopix dermatological compound SYN0126 alone or in combination with the lipid-targeted antioxidant SYN0854, outperformed a marketed cosmetic product containing 2% salicylic acid, producing a 30% mean reduction in total spot count over an eight week period.

The reduction in non-inflamed spots for both of the Syntopix formulations approached the efficacy seen with a number of topical prescription treatments. In contrast, the negative control group managed a mean reduction in non-inflamed spots of just 9.8% whilst the group using the marketed product (positive control) recorded a 7.8% mean increase.

The company believes the positive study results have put it closer to commercialising the product with discussions with potential clients already in place.

“This study confirms that our rigorous screening programme is yielding results.  We are now actively pursuing discussions with leading cosmetic and consumer healthcare companies to investigate the possibility of securing a licensing agreement for SYN0126 and are confident that the positive results from this study will lead to commercial deals in the near future,” said chief executive of Syntopix, Stephen Jones.

A further Phase II cosmetic study is set to take place in the second half of 2010.

Syntopix simultaneously released a business update, announcing its intention to focus on its three most advances compounds, SYN0126, SYN1113 and SYN0017 to accelerate their commercialisation, while continuing its screening programme to identify antimicrobial compounds for use in over-the-counter (OTC) and cosmetic products, particularly those used in skin care, oral care and chewing gum.

The company added that it continued to develop a strong working relationship with Procter & Gamble (NYSE: PG) and was in close collaboration to develop antimicrobials for use in an undisclosed “major consumer healthcare brand” and that it has renewed its exclusivity and evaluation agreement with another “major consumer healthcare company,” announced back in April. Syntopix has also secured its tenth UK patent to protect the SYN0126 compound.

GlaxoSmithKline (GSK) has inked a deal with Astex Therapeutics to discover, develop, and commercialize compounds directed against multiple targets for £20 million (about $33 million) up front. Astex is eligible to development and regulatory milestones of over £300 million (roughly $496.47 million) if all programs are successfully developed and commercialized.

The up-front payment comprises £12.5 million (approximately $20.68 million) in cash and £7.5 million (about $12.41 million) in equity. Milestones include fees related to nonclinical success totaling more than £37 million (roughly $61.23 million). Additionally, Astex is entitled to tiered royalties on each program.

Astex will apply its fragment chemistry platform, Pyramid™, to various targets of interest to GSK. The firms will form joint program teams to identify candidate compounds. Astex will be primarily responsible for initial fragment screening and lead discovery. GSK will primarily be responsible for optimization of the identified lead compounds. Additionally, GSK will be solely responsible for completing preclinical and clinical development of all products arising from the collaboration and for their commercialization globally.

Source: genengnews.com

Shareholders approve sale of the Richmond, Virginia assets as required under the
GL Biochem Asset Purchase Agreement
RICHMOND, Va.–(Business Wire)–
Commonwealth Biotechnologies, Inc. (”CBI”) (NASDAQ Capital Market: CBTE) has
recently announced a definitive share purchase agreement to acquire
Shanghai-based GL Biochem and associated businesses (the “GL Group”), the
largest global supplier of research-grade peptide products and peptide reagents.
Management is pleased to provide a market update regarding the history,
operations and strategy of the GL Group, the industry and marketplace for
peptides and peptide reagents, and progress of the merger transaction.

Background

The GL Group was established in Shanghai by Dr. Hongyan Xu in 1998 and has grown
to become the largest supplier of pre-clinical peptide reagents and custom
peptide synthesis services in the world. The Company has achieved rapid growth
without debt financing or additional capital investment and has expanded the
scale and scope of its operations using only free cash flow from its operations.
Today, the GL Group employees over 800 staff, operates 35,000 ft2 and 120,000
ft2 manufacturing facilities in Shanghai and is in the process of jointly
commissioning a third Shanghai manufacturing facility, `Mimotopes-China`. Over
the past 5 years, the GL Group has demonstrated compound annual revenue growth
of over 40%. Despite the global economic downturn, the GL Group reported a 20%
increase in revenues in the first half of 2009 (unaudited) compared to the same
period last year.

Industry Context

Peptides play an important role in modulating many physiological processes in
the body and therefore have excellent potential as therapeutic agents. Peptide
drugs have a number of advantages over both small molecules and proteins,
including low toxicity and immunogenicity, excellent specificity, high potency
and a low probability of drug-drug interaction problems. Several technical
challenges in the use of peptides as drugs have been overcome in recent years
and they now represent one of the key growth areas in the drug discovery
industry.

Marketplace

GL Biochem caters for the outsourcing requirements of universities, research
institutes, pharmaceutical and biotechnology companies for reagents as well as
research and development services. Large pharmaceutical and biotechnology
companies typically have some capabilities in-house but choose to outsource much
of their research and development work to specialist providers such as GL
Biochem. Pharmaceutical companies are now unable to generate the large number of
necessary candidate compounds in-house and this has led to an increasing trend
for outsourcing of drug discovery research. The worldwide market for custom
peptides was estimated to be between US$250m and US$450m in 2003 and is
projected to grow at an annual average rate of 11.9%, valuing the market between
$550m and $990m by 2010.

Business and Operational Strategy

In recent years, GL Biochem has achieved cost leadership in the research grade
custom peptide industry through exploiting its scale of production, cumulative
experience, competitive labor costs and the manufacture of its own raw
materials. This production cost advantage has allowed GL Biochem to price its
products and services below other major manufacturers and therefore establish a
prominent position in the pre-clinical custom peptide and reagent markets. GL
Biochem sells a portion of its custom peptides and reagent products directly to
the public but also generates significant revenues through an original equipment
manufacturer (”OEM”) strategy, whereby peptides or reagents produced by GL
Biochem are sold to peptide or chemical companies in the West and retailed under
the Western company’s brand name.

Products and Services

GL Biochem develops, manufactures, markets and distributes peptides, peptide
reagents and related services for the life-science sector. GL Biochem`s
offerings include:

* Research-grade peptides: Custom-made peptide molecules for biological research
and drug development applications;
* Peptide libraries: Large numbers of peptides produced in small quantities for
various screening applications in immunology and drug discovery;
* Catalogue peptides: Commonly requested off-the-shelf peptides, typically for
pharmaceutical or cosmetic applications;
* Peptide reagents: Including amino acids, peptide coupling reagents, protecting
reagents and linkers peptide synthesis; and
* Antibodies: Tailored monoclonal and polyclonal antibody production services
for immunology applications.

Merger Progress

On September 3, 2009 CBI entered into a definitive share purchase agreement to
acquire all of the outstanding stock of GL Biochem (Shanghai) Ltd, as well as
all of the outstanding shares of GL Biochem (Danyang) Ltd, GL Peptide (Binhai)
Ltd, and 86% of the shares of GL Peptide (Shanghai) Ltd. Completion of the
transaction is subject to a number of conditions precedent, which among other
things include the sale of the Richmond businesses-CBI Services and Fairfax
Identity Laboratories (collectively, the “Divisions”). The sale of the Divisions
was approved by CBI`s shareholders at the annual meeting of shareholders held on
October 9, 2009. Another material condition is completion of the GL GAAP
qualified audited accounts. These are scheduled for completion on October 15,
2009. Upon fulfillment of these key conditions, CBI anticipates being able to
put the proposed merger to its shareholders for approval by years` end.

About CBI

CBI offers cutting-edge research and development products and services to the
global life sciences industry. CBI now operates through: (1) CBI Services, a
discovery phase contract research organization; (2) Fairfax Identity
Laboratories, a DNA reference business; (3) Mimotopes Pty Ltd, Melbourne,
Australia, a peptide and discovery chemistry business; and (4) Venturepharm
(Asia), a contract research consortium specializing in drug discovery and
development, process scale-up, formulation development, cGMP manufacturing and
clinical trial management. For more information, visit CBI on the web at
www.cbi-biotech.com.

About GL Biochem (Shanghai) Ltd

GL Biochem (Shanghai) Ltd is an international leader in the research,
development, manufacture and marketing of diverse biochemical and fine
chemicals, with a particular strength in peptides, peptide reagents and related
products. With over 800 highly-trained staff and state-of-the-art facilities, GL
Biochem is now the largest manufacturer of research-grade peptides and peptide
reagents globally. For more information visit www.glschina.com.

Forward Looking Statements

No statement made in this press release should be interpreted as an offer to
purchase any security. Such an offer can only be made in accordance with the
Securities Act of 1933, as amended and applicable state securities laws. Any
statements contained in this release that relate to future plans, events or
performance are forward-looking statements that involve risks and uncertainties
as identified in CBI`s filings with the Securities and Exchange Commission.
Actual results, events or performance may differ materially. Specifically, CBI
cannot guaranty that:

* the transaction referenced herein will close;
* the combined companies will perform as anticipated on an ongoing basis;
* the market for peptide drugs will continue to grow as referenced herein; or
* CBI`s shareholders and lenders will approve this transaction.

Readers are cautioned not to place undo reliance on these forward-looking
statements, which speak only as the date hereof. Further, all forward-looking
statements included in this press release are based upon information available
to CBI as of the date hereof. CBI assumes no obligation to update any such
forward-looking statements.

Commonwealth Biotechnologies, Inc.
Richard Freer, COO
804-648-3820

Copyright Business Wire 2009

Liège, Belgium—October 23, 2009.
Eurogentec S.A. (“Eurogentec”) announces today a final agreement for the acquisition of AnaSpec Inc (“AnaSpec” or the “Company”), a privately held proteomics company based in Fremont, California. Founded in 1993, AnaSpec is a leading provider of integrated proteomics solutions for life science research and diagnostics with expertise in peptides synthesis, labeled peptides and antibodies, fluorescent dyes and enzyme activity assays. AnaSpec has developed one of the world’s largest collections of catalog and dye-labeled peptides in the fields of Alzheimer Disease, Multiple Sclerosis and enzyme inhibitor screening. Leveraging its expertise in peptide, antibodies and fluorescent dyes, AnaSpec has established a leading edge portfolio of integrated proteomics solutions such as FRET based assays and SensoLyte™ assays for basic research, high-throughput screening and drug discovery.  Furthermore, AnaSpec’s proprietary fluorescent dyes are being used by the world’s leading diagnostic companies to enhance their diagnostic solutions.
“Bringing AnaSpec into the Eurogentec Group is a strategic decision for our company,” explains Jean-Pierre Delwart, CEO of Eurogentec. “Through this acquisition, Eurogentec  becomes a leading integrated solution provider for the Life Science and Diagnostics sectors. Our combined expertise enables Eurogentec to provide innovative solutions in the fields of Genomics and Proteomics for basic research in the biotech and pharmaceutical sectors, as well as applied solutions in the diagnostics sector. As an example, the HiLyte Fluor™ dyes and QXL™ quenchers that are part of AnaSpec’s high performance detection assays will be integrated into Eurogentec’s comprehensive portfolio of oligonucleotides. This will establish a license-friendly alternative to most dye-labeled oligonucleotides from competitors for commercial and diagnostic applications. Moreover, AnaSpec considerably strengthens Eurogentec’s geographical presence in the US and Eurogentec will directly market and support AnaSpec’s products in the EU.” The founders of AnaSpec, Anita Hong, President, and Frank Hong, CEO, comment: “It is important for the sustained development of AnaSpec to integrate into a larger organization where its current assets and competencies can bring real added value. The total complementarities between Eurogentec’s and AnaSpec’s existing businesses and the cross-fertilization opportunities for future developments are a key factor for the success of this partnership. We are very much looking forward to closely working with the Eurogentec Team from this perspective.”
AnaSpec’s founders and senior management, Anita and Frank Hong, will remain aboard the Company in leading roles in continuing to grow AnaSpec’s businesses, further expanding the high value detection reagents focus and facilitating integration with Eurogentec.  Eurogentec intends to maintain the Company’s state-of-the-art Fremont facility, to which AnaSpec recently moved operations, and its valued employees.
Troutman Sanders LLP served as legal counsel, and Achelous Partners, LLC, served as financial advisers to AnaSpec.  DLA Piper LLP served as legal counsel to Eurogentec on this transaction.

About Eurogentec
Eurogentec is a leading global supplier of innovative reagents, kits, specialty products and custom services to scientists in the life science, biotechnology, pharmaceutical and diagnostic markets. Eurogentec provides a wide range of expertize in small- and large-scale DNA, RNA, PCR and qPCR kits, peptide synthesis and antibody supply for research applications. Our ISO13485:2003-certified manufacturing facilities in Belgium provides a wide range of high value oligonucleotide-based components for diagnostic and therapeutic applications. Eurogentec’s Belgium manufacturing facility is complemented by additional production facilities in North America and Japan. Eurogentec is also an experienced Contract Manufacturing Organization (CMO) for Biopharmaceuticals, operating a full-service, state-of-the-art GMP facility in Belgium.
Eurogentec is a privately held company headquartered in Liège, Belgium, with subsidiaries in North America, France, Germany, the UK, the Netherlands and Switzerland and has additional production facilities in North America, Japan and Singapore. Eurogentec employs 400+ people globally.
Contact Information:
Jean-Pierre Delwart
Chief Executive Officer, Eurogentec
Ph: +32-475-607-884

Philippe Cronet
Chief Scientific Officer, Eurogentec
Ph: +32-4-372-7411

Albert Hong
Business Development Specialist, AnaSpec Inc.
Ph: (800) 452-5530 x243

BIRMINGHAM, Ala.–(BUSINESS WIRE)–DiscoveryBioMed, Inc. (DBM) today announced that it has been awarded a $750,000 Small Business Innovations Research (SBIR) Phase 2 grant by the National Institutes of Health (NIH) to continue the research into the discovery and development of small molecules to alleviate multiple chronic human diseases including cystic fibrosis (CF), hypertension and chronic kidney diseases with hypertension.

“We are proud to have been awarded this grant and to have our technology again recognized and validated by the NIH,” said Dr. Erik Schwiebert, Chief Executive Officer of DiscoveryBioMed. “With our academic partners at the University of Alabama at Birmingham and at Johns Hopkins University School of Medicine, we stand ready to test lead compounds for safety and efficacy in both CF and hypertensive animal models.”

DBM has adapted a known electrical bioassay method to be high-throughput screening friendly, a necessary solution to bring the bioassay to the molecular target endogenous to the apical cell membrane of polarized renal and respiratory epithelia. The molecular target in play for this drug discovery program is an epithelial ion channel that is the rate-limiting step for the handling of salt in the distal portions of the kidney and in the respiratory tract. When over-active, this sodium channel can cause dehydration of the airways and too much salt in the blood, leading to high blood pressure.

“To successfully study this ion channel target, we had to bring the bioassay to the target where it is most comfortable, the apical membrane of a polarized epithelium simulated in in vitro 3D culture,” continued Dr. Schwiebert. “Researchers refer to this target as ‘twitchy’ since it does not behave the same in other experimental systems. It also depends upon factors produced by the epithelium itself to maintain proper activity. DBM brought the assay to the target and remains true to the principle that the target should be endogenous to a human or mammalian epithelial cell system to empower the most biologically-relevant drug discovery program. We believe screening on life-like human cell platforms is essential in development of drugs that ultimately will be provided to human patients.”

Additionally, DiscoveryBioMed has a pair of closely related lead compounds in hand that it will use as a medicinal chemistry platform. Additional hit-to-lead compounds are emerging. At the end of Phase 2, DBM anticipates having pre-clinical animal data and, possibly, proof-of-concept efficacy data in animals and in humans to show to potential out-license partners.

About DiscoveryBioMed, Inc.

DiscoveryBioMed, Inc. is a life sciences and biotechnology company that engages in R&D and services work in cell engineering and production and cell-based drug discovery. The company is located within The Innovation Depot facility in Birmingham, Alabama. Using physiologically relevant cell culture models preferably derived from normal and diseased adult human cells and tissues, DBM focuses on finding therapeutic compounds for a variety of human diseases. It also applies this custom human cell-based approach to its “fee-for-service” support to researchers in allied areas and currently serves clients both locally in Alabama as well as in 11 other states in the US currently. For more information, visit the DBM website at www.discoverybiomed.com.

Source: Businesswire.com

HUENENBERG, Switzerland & ZURICH, Sep 13, 2009 (BUSINESS WIRE) — –Acquisition establishes sustainable platform for ongoing biologics development

–Deal builds on other recent transactions to expand breadth and depth of Alcon’s development opportunities in eye care in the long term

–ESBATech shareholders retain rights to non-ophthalmic technology and products

Alcon /quotes/comstock/13*!acl/quotes/nls/acl (ACL 141.64, +1.02, +0.73%) announced today that it has entered into a definitive agreement to acquire ESBATech AG, a Swiss biotechnology company. Alcon will pay ESBATech shareholders $150 million in cash at closing, plus contingent payments of up to $439 million based upon the achievement of future research and development milestones that would be expected to create value for Alcon. ESBATech is a clinical-stage biotechnology company that has been developing a pipeline of proprietary single-chain antibody fragment therapeutics for topical and local delivery for safe and convenient therapy.

“Biotechnology offers significant growth opportunities in ophthalmology because it has the potential to deliver therapies with superior efficacy and safety relative to existing approaches,” said Sabri Markabi, M.D., Alcon’s senior vice president of research and development and chief medical officer. “Combining ESBATech’s proprietary antibody fragment technology with our expertise in ophthalmic formulation and capabilities in global development will strengthen Alcon’s leadership position in ophthalmology.”

ESBATech has advanced its antibody fragment technology to preclinical and clinical stages in the eye for various diseases. The company has several stable and soluble single-chain antibody fragments in development, with its most advanced product candidate progressed into Phase I and II studies relating to the treatment of inflammatory ocular diseases.

“I am very proud of what our team has achieved in proving clinically that our platform delivers therapeutic antibody fragments with required drug-like properties,” said Dr. Dominik Escher, chief executive officer of ESBATech. “All of us at ESBATech are excited to join with Alcon to advance this technology further and to develop products to treat serious eye diseases so that more patients can see better.”

The agreement to acquire ESBATech includes all rights to its technology for therapeutic application to the eye, including age-related macular degeneration, diabetic macular edema, glaucoma, dry eye and uveitis. Substantially all of the employees of ESBATech will join Alcon upon the finalization of the acquisition. The rights to the technology and products for application outside of ophthalmology will be retained by the previous shareholders of ESBATech and spun off into a separate new company, Delenex Therapeutics AG.

“This acquisition is part of our ongoing strategy to enhance access to multiple sources of technologies and compounds that bolster our total research platform in support of innovative products to treat eye disease,” said Kevin Buehler, Alcon’s president and chief executive officer. “We welcome Dr. Escher and his highly qualified team of biotechnology experts who will become the foundation of Alcon’s biologics capability in the future.”

As confirmation of the strategy to enhance the Alcon research platform, this biologics capability acquisition comes on the heels of Alcon’s recent announcement of an agreement with AstraZeneca that pairs Alcon’s ophthalmic research capability with AstraZeneca’s rich drug libraries in a collaborative effort to treat eye diseases. The ESBATech acquisition expands Alcon’s research capability outside of small molecules to the promising field of proteins, antibodies and other large molecules.

About Alcon

Alcon, Inc. is the world’s leading eye care company, with sales of approximately $6.3 billion in 2008. Alcon, which has been dedicated to the ophthalmic industry for 65 years, researches, develops, manufactures and markets pharmaceuticals, surgical equipment and devices, contacts lens solutions and other vision care products that treat diseases, disorders and other conditions of the eye. Alcon operates in 75 countries and sells products in 180 markets. Alcon’s majority shareholder is Nestle, S.A., the world’s largest food company. For more information on Alcon, Inc., visit the Company’s web site at www.alcon.com.

About ESBATech

ESBATech is a Zurich, Switzerland-based, privately held, clinical stage biotechnology company concentrating in research and development of its antibody fragments for therapeutic applications. ESBATech applies its proprietary screening platform IMMUNA and its fully human single-chain antibody frameworks to generate product candidates against targets of clinical relevance. Prior to the acquisition, the company focused on three franchises: ophthalmology, rheumatology and respiratory, advancing a pipeline of novel antibody fragments for topical and/or local delivery, to ensure safe and convenient patient therapy. For more information about ESBATech, please visit the company’s web site at www.esbatech.com.

Caution Concerning Forward-Looking Statements. This press release may contain forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Any forward- looking statements reflect the views of our management as of the date of this press release with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Except to the extent required under the federal securities laws and the rules and regulations promulgated by the Securities and Exchange Commission, we undertake no obligation to publicly update or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.

SOURCE: Alcon, Inc. and ESBATech AG; Marketwatch.com

HAMBURG, Germany and OXFORD, UK, Sept. 9, 2009 (GLOBE NEWSWIRE) -- Evotec AG
(Frankfurt:EVT) (Nasdaq:EVTC), a leading provider in the discovery and
development of novel small molecule drugs, today announced that it has entered
into a research agreement with Biogen Idec (Nasdaq:BIIB), a leading
biopharmaceutical company headquartered in Cambridge, Mass., USA.

Evotec will use its expertise and technologies in protein production, assay
development and high throughput screening to identify hit molecules for Biogen
Idec. Under the research agreement Evotec will screen a target selected by
Biogen Idec with the option to add further targets as agreed. Evotec will
provide Biogen Idec with access to its full range of screening technologies and
diverse library of high quality compounds and will use its expertise in protein
production and assay development to develop new assays for the target.

Dr. Mark Ashton, Evotec's EVP, Business Development commented: "We believe that
the quality of future drug candidates is very much dependent on the
identification of high quality starting points. To this end we have established
a platform of screening technologies that have been proven to identify
high-class hit molecules. We are looking forward to working with Biogen Idec and
identifying interesting hit compounds for them."

Evotec has built a comprehensive platform of hit finding technologies that allow
it to screen challenging targets and identify new classes of hit compounds that
can be progressed towards new treatments for various diseases. These proven
screening technologies coupled with Evotec's high quality screening library have
been shown to unlock numerous biological targets and identify excellent start
points for subsequent optimization.

No financial details are disclosed.

About Evotec AG

Evotec is a leader in the discovery and development of novel small molecule
drugs. The Company has built substantial drug discovery expertise and an
industrialized platform that can drive new innovative small molecule compounds
into the clinic. In addition, Evotec has built a deep internal knowledge base in
the treatment of diseases related to neuroscience, pain, and inflammation.
Leveraging these skills and expertise the Company intends to develop
best-in-class differentiated therapeutics and deliver superior science-driven
discovery alliances with pharmaceutical and biotechnology companies.

Evotec has long-term discovery alliances with partners including Boehringer
Ingelheim, CHDI, Novartis, Ono Pharmaceutical and Roche. The Company has a P2X7
antagonist for the treatment of inflammatory diseases in clinical development
and a series of preclinical compounds and development partnerships, including a
strategic alliance with Roche for EVT 101, a subtype selective NMDA receptor
antagonist, for use in treatment-resistant depression. For additional
information please go to www.evotec.com

Forward-looking statements

Information set forth in this press release contains forward-looking statements,
which involve a number of risks and uncertainties. Such forward-looking
statements include, but are not limited to, statements about our expectations
and assumptions concerning regulatory, clinical and business strategies, the
progress of our clinical development programs and timing of the results of our
clinical trials, strategic collaborations and management's plans, objectives and
strategies. These statements are neither promises nor guarantees, but are
subject to a variety of risks and uncertainties, many of which are beyond our
control, and which could cause actual results to differ materially from those
contemplated in these forward-looking statements. In particular, the risks and
uncertainties include, among other things: risks that the Company may be unable
to reduce its cash burn through recent restructuring and cost containment
measures and may not recognize the results of such measures within the expected
timeframe; risks that product candidates may fail in the clinic or may not be
successfully marketed or manufactured; the risk that we will not achieve the
anticipated benefits of our collaborations, partnerships and acquisitions in the
timeframes expected, or at all; risks relating to our ability to advance the
development of product candidates currently in the pipeline or in clinical
trials; our inability to further identify, develop and achieve commercial
success for new products and technologies; the risk that competing products may
be more successful; our inability to interest potential partners in our
technologies and products; our inability to achieve commercial success for our
products and technologies; our inability to protect our intellectual property
and the cost of enforcing or defending our intellectual property rights; our
failure to comply with regulations relating to our products and product
candidates, including FDA requirements; the risk that the FDA may interpret the
results of our studies differently than we have; the risk that clinical trials
may not result in marketable products; the risk that we may be unable to
successfully secure regulatory approval of and market our drug candidates; and
risks of new, changing and competitive technologies and regulations in the U.S.
and internationally. The list of risks above is not exhaustive. Our most recent
Annual Report on Form 20-F, filed with the Securities and Exchange Commission,
and other documents filed with, or furnished to the Securities and Exchange
Commission, contain additional factors that could impact our businesses and
financial performance. We expressly disclaim any obligation or undertaking to
release publicly any updates or revisions to any such statements to reflect any
change in our expectations or any change in events, conditions or circumstance
on which any such statement is based.

Source: Reuters