Biogen Idec has entered into a definitive agreement to acquire Stromedix, a privately-held clinical stage biotech company specialized in experimental treatment of fibrosis. The deal could be worth up to $562 million.

The Weston, MA-based Biogen said the company will buy Stromedix with an upfront fee of $75 million and additional contingent value payments of up to $487.5 million on the achievement of development and approval milestones across multiple indications.

The acquisition deal enables Biogen put Stromedix’s lead candidate, STX-100 into its development pipeline. The experimental drug is a novel humanized monoclonal antibody that will be entering a mid-stage trial in patients with idiopathic pulmonary fibrosis.

Stromedix said it has identified a series of clinical biomarkers that reflect the biological activity of STX-100, which selectively targets integrin αvβ6, preventing αvβ6 from binding to latent TGFβ complex and converting it to active TGFβ, a process that plays a central role in fibrotic disease.

Pre-clinical study found the experimental agent shows significant anti-fibrotic activity in animal models of lung, kidney and liver disease. It was also showed in an early-stage trial the agent has “an attractive safety and tolerability profile,” according to the company.

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive form of fatal lung disease characterized by fibrosis (scarring) of the supporting framework of the lungs. Patients with IPF experience progressive difficulty breathing due to fibrosis of the lung. The condition in IPF has been associated with smoking, gastroesophageal reflux disease and autoimmune disorders, but none of these are present in all patients with IPF, and therefore do not provide a completely satisfactory explanation for the disease. It is estimated that more than 200,000 patients in the United States and Europe have IPF. More than 5000 people died of this disease in the UK each year. Current there is no FDA-approved treatment for IPF. The U.S. agency has granted orphan drug designation to STX-100 for the treatment of IP in August 2010.

Other investigational treatments for IPF include Boehringer Ingelheim’s Nintedanib, a small molecule anti-vascular agent in phase III trial for patients with the non-cancerous lung condition IPF; and QAX576 from Novartis had been studied in phase II trial for IPF patients.

Douglas Williams, head of R&D at Biogen, said: “Fibrotic organ failure and in particular IPF is a terrible disease with a high mortality rate, and there are no effective treatments at this time. We believe STX-100 has the potential to be a best-in-class therapy, and it is an excellent strategic fit with our focus on highly differentiated programs with the potential to make a real difference for patients.”

The Cambridge, MA-based Stromedix also has a compound in pre-clinical research that could be used as a treatment for inflammation caused injury.

Valeant has added another biotech firm on its shopping list by announcing the plan to acquire the Florida-based eye care specialist Eyetech.

Headquartered in Mississauga, Ontario, the Canadian company Valeant has been on the acquisition trail since its merger with Biovail Corporation  in September, 2010. Last year has seen the company put the Australian drug firm iNova, generic drug maker Pharma Swiss and AB Sanitas , dermatology specialist Dermik and Ortho Dermatologics into its shopping cart.

Valeant last month withdrawn its offer to acquire another eye drug specialist ISTA Pharmaceuticals for$7.50 per share in cash, saying the company is not interested in participating in a lengthy evaluation process. 

The privately-owned Eyetech is an ophthalmic specialist with product focused on treatments for sight-threatening diseases of the retina. Valeant said the acquisition of Eyetech would include an upfront payment and possible future milestones. Although the financial details were not released, it says the total value is “significantly less than two times sales” of the Florida-based biotech firm.

Eyetech currently sells Macugen (pegaptanib sodium) in the U.S. market. The drug is the first anti-vascular endothelial growth factor (VEGF) inhibitor approved for the treatment of wet age-related macular degeneration,  a major cause of blindness and visual impairment in older adults. Pfizer holds the right to the drug in other places of the world.

J. Michael Pearson, chairman and CEO at Valeant said in a statement: “This acquisition of Eyetech will fit nicely with our existing ophthalmology business.”

Valeant’s own ophthalmology products include a preservative-free formulation of Timoptic (timolol maleate) and dry eye treatment Lacrisert (hydroxy propyl cellulose ophthalmic insert), both obtained from its acquisition of Aton Pharma in 2010. 

“The ophthalmology market has similar characteristics to the dermatology space and is a natural extension of our development capabilities.  We will continue to look for future opportunities to acquire additional products and gain important critical mass in this specialty space,” J. Michael Pearson added.

The two companies are expected to close deal within a week.

Bristol-Myers Squibb is going to acquire Inhibitex Inc, a biopharma developer dedicated to infectious diseases. The $2.5 billion cash deal will boost BMS development  pipeline in hepatitis C treatments.

The companies announced in a statement that BMS will pay $26 a share through a two-step merger, beginning with a tender offer of 163% premium over Inhibitex’s Friday closing price. Boards of both firms have approved the deal.

However, in a following statement,  Georgia-based Inhibitex said the Law Office of James C. Kelly is investigating potential claims against the board of directors of the company concerning possible breaches of fiduciary duty and other violations of law related to the acquisition deal. The law firm concerns whether the board of directors adequately shopped the company to obtain the best price possible for the Company’s shareholders before entering into the agreement.

Bristol-Myers Squibb’s acquisition of Inhibitex will strengthen the drug maker’s portfolio of hepatitis C treatments, a market that estimated at about $20 billion by 2020.

Inhibitex’ pipeline focused on the potential treatment of infectious diseases, including viral and bacterial infections such as chronic hepatitis C, shingles and MRSA infections. The company’s leading candidate INX-189, an oral nucleotide polymerase inhibitor is under Phase 2 development for the treatment of chronic hepatitis C infections.

Inhibitex reported top-line safety and antiviral results of  the first cohort of this ongoing mid-stage trial of INX-189 in November 2011. The experimental drug demonstrated significant dose-dependent antiviral activity at 200 mg once-daily dose or at 100 mg once-daily dose in combination with ribavirin.   INX-189 was generally well tolerated, and there were no serious adverse events or dose dependent adverse events observed.

Lamberto Andreotti, CEO of Bristol-Myers Squibb, said the acquisition represents an important investment in the long-term growth of the company

“The acquisition of Inhibitex builds on Bristol-Myers Squibb’s long history of discovering, developing and delivering innovative new medicines in virology and enriches our portfolio of investigational medicines for hepatitis C,” said Lamberto Andreotti.

BMS has already in a strong postion in developing potential hepatitis C therapy. Its pipeline assets include BMS-790052, an NS5A replication complex inhibitor and BMS-650032, an NS3 protease inhibitor), both are under clinical studies.

Elliott Sigal, CSO and president, R&D, Bristol-Myers Squibb, said “The addition of Inhibitex’s nucleotide polymerase inhibitor to our own promising portfolio, which includes other direct-acting antivirals, brings additional options to develop all-oral regimens with better cure rates, shorter duration of therapy and lower toxicity than the current standard of care.”

The BMS deal  marks another acquisition deal for hepatitis C assets,  following Gilead Sciences’ decision to buy experimental hepatitis C drug maker Pharmasset Inc. for $10.8 billion at a 94 percent premium. Analysts have suggested that a drug developer with hepatitis C pipeline could be a takeover target, since the lucrative market of the high prevalent HCV in large sections of the global population. Roche agreed in October to buy Anadys Pharmaceuticals Inc., another maker of experimental medicines for hepatitis C, for about $230 million.

An estimated four million people in the U.S. are infected with hepatitis C, with only a quarter of those diagnosed and even fewer have received treatment.  The anti hepatitis C drug development had drawn huge interest from pharma industry over the last a couple of years. New therapies from Merck & Co. (Boceprevir) and a collaboration between Johnson & Johnson and Vertex (Telaprevir) have been approved last year by U.S. FDA.

Russell Plumb, President and CEO Inhibitex, said, “Bristol-Myers Squibb’s expertise in antiviral drug development, and its existing complementary portfolio, will assure that the potential of INX-189 is realized as part of future oral combination therapies for millions of patients in need around the world.”

Alexion Pharmaceuticals has signed an agreement to buy Enobia Pharma, a Canadian drug developer firm that is focused on treatments for patients with rare and life-threatening genetic metabolic disorders, with up to $1.08 billion cash.

The Cheshire-based pharmaceutical company Alexion said  it will pay $610 million in cash for the Montreal-based company and up to $470 million in additional payments based on regulatory and sales-related milestones. Both companies anticipate that the acquisition deal will be completed in the first quarter of 2012. The transaction is still subject to customary conditions, including the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

The deal will give Alexion full access to Enobia’s lead drug candidate, Asfotase Alfa (ENB-040), an experimental enzyme therapy in Phase II study for hypophosphatasia (HPP). The ultra-rare disease hypophosphatasia (HPP) is a genetic metabolic disorder that can cause skeletal deformity, severe muscle weakness, seizures and progressive damage to vital organs that can lead to impaired renal function, and respiratory failure.

Hypophosphatasia, caused by a mutation of the gene for alkaline phosphatase, only affects a few thousand patients in the U.S. However, currently, there is no approved treatments for the fatal genetic disease.

Asfotase Alfa  is a human recombinant targeted alkaline phosphatase enzyme-replacement therapy that  is currently in mid-stage trial. The product is designed to replace the deficient natural enzyme, with improved pharmacokinetic properties aimed to target the drug specifically to bone. Asfotase alfa has obtained orphan drug status in both U.S. and Europe, and has been granted fast-track status by the FDA.

“We’re excited to add this highly promising and innovative late-stage product to the pipeline,” said Leonard Bell, chief executive of Alexion, “Asfotase alfa has shown very compelling Phase II clinical data in infants and juveoth niles with hypophosphatasia. The acquisition of Enobia is very well aligned with Alexion’s objective to develop and deliver life-transforming therapies for patients suffering with ultra-rare, severe, and life-threatening disorders.”

With its sole marketed product, Soliris, Alexion focuses on ultra-rare diseases for which there are no other approved therapies;

Alexion currently has only one marketed product, Soliris (eculizumab), a fully humanized monoclonal antibody targeted at complement protein C5. The drug is indicated for treating paroxysmal nocturnal hemoglobinuria (PNH), a rare and sometimes life threatening disease of the blood.  The drug Soliris, at $409,500 a year, is marked as the world’s single most expensive drug.

At the end of the year 2011, Alexion’s acquisition of Enobia is one of the largest biotech deals of the year..

Pfizer will buy Excaliard, a privately owned biopharmaceutical company focused on developing novel drugs for the treatment of skin fibrosis.

The firms announced today that they have entered into a definitive agreement for the acquisition deal, which is expected to close before the end of the year. The financial details were not disclosed.  

UCB said Tuesday the company has acquired the key pharmaceutical assets of the UK’s Lectus Therapeutics via a licence and acquisition agreement. The deal is expected to strength the company R&D efforts in the central nervous system.

UCB will get Lectus Therapeutics’ drug discovery and development programmes targeting ion channels for the treatment of a specific set of central nervous system disorders through the acquisition,  said The Brussels, Belgium-based biopharma. In addition, UCB will also gain exclusive worldwide rights to commercialise products discovered from the use of Lectus’s proprietary LEPTICS technology for a number of further ion channel targets.

Financial details of the transaction were not disclosed.

“We are pleased to close this transaction with UCB and anticipate that the competitive edge LEPTICS® brings, together with the enthusiasm and expertise of UCB’s team, will lead to success in this challenging area of research and development,”  said Dr Roland Kozlowski, CEO of Lectus, ”This deal executed with one of the leading global biopharmaceutical companies highlights the potential of Lectus’s approach to ion channel drug discovery and the value of its LEPTICS® technology.”

UCB has a strong product portfolio focused on central nervous system disorders and immunology diseases. The anti-epilepsy drug Vimpat was approved in the U.S.  for partial-onset seizures in 2008 and in the same year in EU as adjunctive therapy in the treatment of partial onset seizures.

Gilead Science said on Monday that it would acquire Pharmasset in an $11 billion cash deal betting the investment on its experimental hepatitis C medicine.

The acquisition offer at $137 per share represents an 89 percent premium over the stock’s latest closing price on Nov. 18. The deal gives Gilead rights to three potential treatments under clinical development for the chronic hepatitis C from the Princeton, New Jersey-based Pharmasset.

Gilead Chief Executive Officer John C. Martin said in the statement, “The acquisition of Pharmasset represents an important and exciting opportunity to accelerate Gilead’s effort to change the treatment paradigm for HCV-infected patients by developing all- oral regimens for the treatment of the disease regardless of viral genotype”.

Hepatitis C, caused by the hepatitis C virus, affects primarily the liver,  (HCV).  The viral infection that often has no symptoms can lead to scarring of the liver and ultimately to cirrhosis and life-threatening liver. Hepatitis C is the primary cause of liver transplants in the United States.  An estimated 180 million people worldwide are infected with hepatitis C.

Pharmasset has been one of the biotech firm with development pipeline based on the promise of its experimental hepatitis C drugs. The company says it will start two other phase 3 studies in 2012 and hopes to file for marketing approval of PSI-7977, the leading candidate received Fast Track Designation from the FDA,  in the United States and European Union in the second half of 2013.

Pharmasset plans to run a 12-week study that treats hepatitis C with a combination of PSI-7977 and ribavirin, both of which are given orally.

Schaefer Price, president and CEO of Pharmasset, said Gilead’s “established expertise and leadership in the field of antiviral drug development and commercialization” makes it a good match for Pharmasset.

Swiss pharma Ferring says that it has completed the purchase of Cytokine PharmaSciences, an US drug firm and its UK subsidiary Controlled Therapeutics, a global biopharmaceutical company with a particular focus in obstetrics.

Ferring believes the acquisition will expand its leading position in reproductive health over the next few years. The financial details of the deal were not disclosed.

Michel Pettigrew, president of the executive board and chief operating officer at Ferring commented: “This acquisition advances our vision to become the global scientific and commercial leader in reproductive health, and perfectly complements our already strong portfolio of obstetrics products including Tractocile (atosiban) and Pabal (carbetocin),”

He added,” In addition, the acquisition includes the manufacturing assets for dinoprostone marketed by Forest Laboratories, as Cervidil in the USA and Canada, and by Ferring as Propress elsewhere. This acquisition gives us the opportunity to integrate the product portfolio into Ferring on a global basis and to extend our presence in this important field”.

The firm says there are 130 million babies born globally each year and, depending on the country, labour induction rates range from 15% to 30% of all births. Treatments for “cervical ripening are set to play an increasingly prominent role in the delivery process”, it notes.

The acquisition marks the second major investment of Ferring in the therapeutic field in two years. The company bought the global marketing rights for Lysted (tranexamic acid) for the treatment of heavy menstrual bleeding, from Xanodyne last year

The UK unit Controlled Therapeutics has also developed a strong pipeline of women’s health care products, including the misoprostol vaginal insert which is intended to be marketed in the USA and Canada as Misodel and in Europe and the rest of the world as Misopress. It is anticipated that the new treatment will be filed for US Food and Drug Administration approval in 2012.

Bristol-Myers Squibb has made a move to acquire potential drug candidates for lung disease and inflammation, agreeing to buy venture-backed biotech company Amira Pharmaceuticals.

The deal gives the New York based BMS footing in a hot field involving drugs against pulmonary fibrosis, a lung disease for which there are no FDA-approved treatments. BMS will pay $325 million upfront and committed up to $150 million in additional milestone payments to Amira’s investors.

Amira’s scientists in San Diego are expected to keep advancing the firm’s research after the deal closes. Some of the hot commodities the group has been working on include AM152, a small molecule LPA1 receptor antagonist that it’s gearing up to move into mid-stage development for pulmonary fibrosis and scleroderma, as well as a preclinical autotaxin program. Amira CEO Bob Baltera made the tough call to trim the staff last fall at Amira–which was founded in 2005 by Merck vets Peppi Prasit, Jilly Evans and John Hutchinson–in part to focus the firm’s resources on ushering its drugs through trials.

Pulmonary fibrosis drugs have drawn significant interest in recent years. Gilead Sciences ($GILD) shelled out $225 million last year to scoop up Arresto BioSciences to boost its R&D in the area, Reuters reported. And InterMune’s ($ITMN) stock price rallied after the European Commission approved its pulmonary fibrosis drug Esbriet (pirfenidone). Another contender in this market is Stromedix, a venture-backed upstart pursuing mid-stage data on its IPF drug STX-100.

“As part of the continued execution of our focused biopharma strategy, Bristol-Myers Squibb has identified fibrotic diseases as an area of high unmet medical need that complements our research efforts in several of our therapeutic areas,” said Elliott Sigal, the company’s president of R&D.

The Japanese drugmaker Daiichi Sankyo is to buy Plexxikon acquiring rights to the company’s much-touted melanoma drug PLX4032, which is still in late stage development.

 Under the terms of the deal, Daiichi Sankyo will pay the privately held  Plexxikon $805 million on a debt-free basis and additional potential payments totaling $130 million based on near-term launch milestones with respect to PLX4032 in malignant melanoma. Daiichi Sankyo will gain certain co-promotion rights in the USA for PLX4032, also known as RG7204, which is being jointly developed by Plexxikon and Roche.

In January, Interim results from a Phase III trial showed that  PLX4032 met co-primary endpoints of overall survival and progression-free survival in patients with previously untreated metastatic melanoma expressing the BRAF mutation.

 Daiichi Sankyo said PLX4032 is “an elegant example of a targeted therapeutic designed to be administered to patients likely to respond to treatment on the basis of a companion diagnostic test that can detect the presence of a specific genetic mutation”. The company also praised Plexxikon’s “unique, systematic, cost-effective” drug discovery platform which “uses structural data to guide chemistry to develop early leads for multiple targets”. 

 Joji Nakayama, the Daiichi Sankyo chief executive, said the acquisition “not only accelerates our entry into the oncology market but strengthens our pipeline”.

Plexxikon, which was established in 2001 and has 45 employees, is also conducting Phase I studies of kinase inhibitors for rheumatoid arthritis and metastatic cancer.