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Sponsored by Kimberly Vaughn, Executive Strategies - Excellence in Executive Search · Medicines for rare disorders and diagnosing diseases contributed to a jump in US drug approvals last year from a quarter-century low in 2007. The FDA cleared 25 novel treatments in 2008, up from 19 the previous year, the most since 2004. The list excludes reformulated drugs and those that have been previously approved for other uses. Among the new medicines were Nplate from Amgen (Thousand Oaks, CA) to treat a bleeding disorder afflicting 60,000 Americans. GlaxoSmithKline and Ligand Pharmaceuticals (San Diego, CA) were cleared to sell Promacta for the same condition. Regeneron Pharmaceuticals (Tarrytown, NY), whose biggest shareholder is Sanofi-Aventis, put its first drug on the market, Arcalyst, for a group of inflammatory diseases diagnosed in about 500 people in the US. Also on the list of treatments for rare disorders was Cinryze, owned by ViroPharma (Exton, PA) through the October acquisition of Lev Pharmaceuticals. It was approved for hereditary angioedema, an inflammatory disease with about 10,000 sufferers in the US. Four approvals were for injected products that help diagnostic equipment produce images, including General Electric’s AdreView for detecting rare tumors in adults and children. The FDA also cleared a sedative for patients undergoing diagnostic procedures using scopes. Two drugs were approved for constipation from surgery or painkillers. · Advaxis (North Brunswick, NJ) said the FDA gave it a go-ahead to test Lovaxin C on certain patients. The drug targets cervical intraepithelial neoplasia, a condition that can lead to cervical cancer. The company now plans to start the second round of trials by September. · Ark Therapeutics (UK) said that European officials have agreed to accept its brain cancer drug Cerepro for approval. The agreement is significant because it is one of the first gene-based drugs to be cleared for approval worldwide. Introgen (Austin, TX) submitted its Advexin gene-based therapy for head and neck cancer for approval in Europe and the US in July last year. So-called gene-based therapies differ from gene therapies in that they only have a temporary effect on the patient's genes. · BioMarin Pharmaceutical (Novato, CA) agreed to pay as much as $289 million to La Jolla Pharmaceutical (San Diego, CA) for Riquent, an experimental treatment for the autoimmune disease lupus that has failed in two earlier studies. Riquent has the potential to become BioMarin’s largest product and create significant shareholder value. If approved by the FDA, Riquent would be the first new drug cleared specifically for lupus in more than 45 years. · Cell Therapeutics (Seattle, WA) received $7.5 million pursuant to the formation of a joint venture with Spectrum Pharmaceuticals (Irvine, CA). RIT Oncology was created to develop and commercialize lymphoma drug Zevalin in the US. Biogen Idec (Cambridge, MA) developed the drug and sold it to CTI in August 2007 for $10 million upfront. The FDA also accepted for filing and has granted priority review status for an sBLA for use of Zevalin as a consolidation therapy in patients with follicular B-cell non-Hodgkin's lymphoma who achieve a response to first-line therapy. A decision is expected in early April. · A drug used to suppress the immune system in cancer and rheumatoid arthritis has helped extend the life of a Minnesota boy struggling with a rare and deadly form of the genetic disorder Pompe disease. A team of researchers led by Children's Hospitals and Clinics of Minnesota used a novel treatment plan using Rituxan, a drug used for non-Hodgkin's lymphoma and rheumatoid arthritis made by Genentech (South San Francisco, CA). · 2008’s M&A activity is underway with Endo Pharmaceuticals’ (Chadds Ford, PA) agreement to acquire Indevus Pharmaceuticals (Lexington, MA) for an initial $370 million as it looks to expand beyond the competitive pain market and gain drug delivery technologies. Endo has found itself in an increasingly competitive market for pain treatments, with King Pharmaceuticals’ (Bristol, TN) acquisition of Alpharma creating a dominant force in the sector. This may be a factor in Endo seeking additional revenue streams in new markets, with the acquisition giving it treatments for overactive bladder, prostate cancer and central precocious puberty. Through the acquisition Endo will gain three products currently on the market, in addition to one that is in Phase III trials. · An FDA evaluation found that the drug Atryn is effective and safe. The drug is being produced by GTC Biotherapeutics (Framingham, MA) for use in people with a hereditary disorder that makes them vulnerable to life-threatening blood clots. If the drug is approved, it would be the first application under new FDA regulations that allow animals to be genetically altered to produce drugs, model human disease, produce industrial or consumer products or improve their use as food. · MedImmune (Gaithersburg, MD), a subsidiary of AstraZeneca, has applied to sell its flu-fighting nasal spray in Europe, potentially spreading the FluMist brand beyond the US for the first time. The company has been selling FluMist in the US since its approval in 2003, and recently launched a refrigerator-safe version of the intranasal spray. · Onyx Pharmaceuticals (Emeryville, CA) said it licensed compounds with the potential to treat cancer and autoimmune diseases for $25 million from S BIO (Singapore). Under the deal, Onyx has exclusive rights to develop and sell two compounds for all their potential uses in the US, Canada, and Europe. Onyx is currently partnered with Bayer on the FDA-approved kidney and liver cancer drug Nexavar. · For $60 million upfront, Plexxikon (Berkeley, CA) has granted Roche worldwide, exclusive rights to its Phase I candidate for polycystic kidney disease, PLX5568. Roche may also license other selective Raf inhibitors resulting from the partnership. · Three years after it launched, Satori Pharmaceuticals (Cambridge, MA), developer of drugs for neurodegenerative disorders, reports it has taken its first full round of venture funding, worth $22 million, and added a seasoned CEO. Joining Satori as its new CEO is Jeffrey Ives, former senior vice president at Pfizer. · Wyeth may become one of the world’s biggest vaccine makers with the acquisition of Crucell (Netherlands), a developer of medicines against AIDS, rabies, and Ebola. The drugmaker is in talks to buy Crucell for $1.35 billion, according to a person familiar with the deal. Crucell had a market value of $1.03 billion. Crucell’s best-selling product is Quinvaxem, a liquid vaccine co-developed with Novartis and introduced in 2006 that protects against five childhood diseases including pneumonia and whooping cough. · The number of public biotechs will plummet in 2009 to 250 as difficulties in securing funding results in mergers, acquisitions and bankruptcies, according to Steve Burrill. Part of this reduction will result from the mergers of biotechs with similar therapeutic focuses. Other companies will be acquired by big pharma and biotech, with Burrill predicting that prices will be equivalent to those in 1990. Burrill believes that the financial straightjacket imposed on small biotechs presents big companies with the luxury of sitting back and waiting for the right opportunities. With regards to big companies in big deals, Burrill predicts that the Roche-Genentech saga will reach a successful conclusion, with the Swiss pharma giant finally completing the acquisition.
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