Industry Insight with Chester: A Collection of Current Industry Updates

Welcome to another posting of ‘Industry Insight with Chester’, a periodic round-up of news and views from around the Pharma and biopharma industries compiled by Chester Solack, Business Analyst at SAFC in Lenexa, Kansas.

Novo Nordisk’s “Treciba” approved in Japan – 28 Sep 12

While it is still waiting on a decision from the FDA, Denmark’s Novo Nordisk has gotten got Japanese approval for its long-acting insulin Tresiba, a drug that could possibly rival Sanofi’s blockbuster Lantus.

Novo Nordisk scraps Vatreptacog Alfa (Fact-Acting factor VIIa) – 28 Sep 12

Danish drugmaker Novo Nordisk has killed development of a hemophilia med once hailed as a successor to its blockbuster product for the bleeding disorder, after the company discovered anti-drug antibodies to the experimental factor VIIa therapy in some study patients, Reuters reported. The setback hampers the company’s work on building its hemophilia franchise as competitors such as Biogen Idec seek entry to or growth in the market. Anti-drug antibodies present a risk to patients with hemophilia who count on injected clotting factors to arrest bleeding. Novo Nordisk says that it first revealed Aug. 9 that a few patients in its late-stage study developed antibodies against its fast-acting factor VIIa, called vatreptacog alfa, with the antibodies having a neutralizing effect in one patient. The company was quick to note in its release Friday that no such antibodies have been reported in patients on marketed hemophilia drug, NovoSeven, while taking inhibitors to factor VIII and factor IV.

Jefferies Analyst thinks Roche should buy Abbvie or BMS – 28 Sep 12

Jefferies analyst Jeffrey Holford this week suggested that Roche needs some growth and that buying AbbVie after its Jan. 1 spinoff would be a good move, The Deal Pipeline reports. He, like everyone else, points to AbbVie’s big money minter, Humira, as a terrific addition to Roche’s dominant position in oncology. The rheumatoid arthritis drug earned Abbott $7.9 billion last year. If not AbbVie, he suggested Bristol-Myers Squibb ($BMY) as an M&A target. And how much might Roche pay for AbbVie? Holford says $69 per share, or $105 billion, which would be a 25% premium to the $55 per share, $84 billion valuation, his company has put on the spinoff. For BMS, he suggests a buyout of $41 per share, $66 billion. That would be a 25% premium to the $33 per share it has been trading around.

Medtronic acquires China’s Kanghui Holdings for $816M – 28 Sep 12

Last month, Medtronic said it was shopping around in China for M&A opportunities, and now the device giant has made a purchase: China Kanghui Holdings ($KH) for $816 million in cash. Kanghui is a maker of orthopedic technologies, boasting a portfolio of trauma, spine and joint reconstruction devices. The acquisition is the largest one Medtronic has ever made in China, Bloomberg notes, and absorbing Kanghui’s business will help Medtronic get 20% of its revenue from emerging markets by 2016, one of CEO Omar Ishrak’s stated goals. Medtronic has had China in its sights for a few years, buying a 15% stake in devicemaker Shandong Weigao in 2007 and unveiling a new R&D shop in Shanghai last month. The Kanghui acquisition gives the company a greater presence in one of the world’s fastest-growing medical device markets, Executive Vice President and President of Medtronic’s Restorative Therapies Group Chris O’Connell said in a statement.

Vertex axes one Hep C molecule but moves forward with another – 25 Sep 12

A little more than a year after Vertex licensed in a pair of “nucs” from Alios BioPharma in a high-stakes bid to develop an oral, interferon-free approach to hepatitis C, Vertex  is jettisoning one as a dud while racing ahead with the second into a mid-stage study slated to begin in a matter of weeks

Mallinckrodt acquires CNS Therapeutics – 25 Sep 12

Like its much bigger counterpart Abbott Laboratories, device-and-drug maker Covidien is plotting a spinoff of its pharma unit, Mallinckrodt. And it’s beefing up that division in advance of the sale, set to be completed next year. Now valued at about $2 billion, Mallinckrodt has agreed to buy the privately held drugmaker CNS Therapeutics for $100 million. CNS has one marketed product–Gablofen, used to treat severe spasticity–and a pipeline of pain and spasticity treatments. The deal is expected to close later this year. “CNS Therapeutics’ marketed product line complements our branded portfolio,” Mallinckrodt President Mark Trudeau said in a statement. “Their central nervous system and pain management products in development complement our pipeline and address an important need for patients.”

Roche and Galaxy Biotech sign antibody agreement – 24 Sep 12

Galaxy Biotech, a Sunnyvale, CA-based lab founded by some high-profile investigators, has picked up an $8 million upfront fee from Roche, which has in-licensed the rights to a portfolio of their antibodies for cancer drug research. The biotech reports that the pharma giant has also committed itself to an undisclosed slate of milestones and royalties for the antibodies, which target fibroblast growth factor 2, a key target in metastasis. Roche says it’s been impressed by the animal data it’s seen so far, indicating that the antibodies have the potential to inhibit tumors in humans. “Galaxy’s humanized monoclonal antibody to FGF2 has demonstrated considerable promise in preclinical studies, and we look forward to developing this and possibly other derivative compounds to complement Roche’s already strong portfolio of antibody products in the oncology field,” says Mike Burgess, acting head of Roche Pharma Research and Early Development.

MacroGenics and Servier enter into Cancer-drug deal – 20 Sep 12

MacroGenics has landed another pharma deal. This time, the biotech has sealed a second pact with French drugmaker Servier, which has tapped MacroGenics’ Dual-Affinity Re-Targeting (DART) platform in an option-based deal focused on bi-specific antibodies against three mystery cancer-immune targets, the U.S. biotech announced this morning. With plans to beef up its oncology franchise, Servier has paid the Rockville, MD-based biotech $20 million upfront for the option to commercialize the three bi-specific antibodies in markets outside the U.S., Canada, Mexico, Japan, Korea and India. MacroGenics, which could reap up to $1.1 billion in payments from Servier in the deal, has nailed down agreements with three major drugmakers for candidates from its DART platform. Pfizer and Boehringer Ingelheim inked deals with the drug developer announced in October 2010 on the strength of the platform.

Boston Sci acquires BridgePoint Medical – 19 Sep 12

Boston Scientific is buying BridgePoint Medical, a maker of catheter-based blood-flow-restoration devices, looking to add marketable technology to its flagging cardiac business. Boston Sci didn’t disclose the financial terms of the deal, but the company will get BridgePoint’s CrossBoss catheter and Stingray CTO re-entry system, two FDA-cleared devices designed to break through blocked coronary arteries and restore blood flow, all without bypass surgery. “The BridgePoint Medical CTO system is a compelling addition to our industry-leading suite of cardiology products,” Kevin Ballinger, president of the Boston Sci’s interventional cardiology unit, said in a statement. “This acquisition strengthens our portfolio and demonstrates the Boston Scientific commitment to continued leadership in interventional cardiology.”

API supply issues force Lundbeck to discontinue Elspar – 18 Sep 12

Undermined by supply-chain issues, Danish drugmaker Lundbeck will discontinue supplying its leukemia drug Elspar beginning in December. Roger Keding, Lundbeck’s vice president for supply-chain management, notified physicians of the decision in a letter last month. He said the company has already invested heavily updating the drug but has had difficulty getting a constant supply of the API to manufacture it. In an email to FiercePharmaManufacturing, Lundbeck Senior Manager of Communications Matt Flesch said, “As noted in the letter, our decision to discontinue Elspar was based on two main factors. First and most importantly, other forms of asparaginase are currently available, which means that patients in need of this therapy will continue to have alternatives. Secondly, there are numerous challenges associated with securing a reliable global and long-term product supply chain.”

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