January 6, 2015 - Bio Space
Amgen is swooping in on a hot new cancer therapy, announcing Monday that it will partner with Kite Pharma (KITE) on a strategic research and licensing collaboration worth an initial $60 million to develop and commercialize novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy (eACT) platform. CAR-T therapy has been a hot commodity for biotech investors for the last few quarters, an importance recognized by the deal size, which has Amgen putting in $60 million, as well as funding for research and development costs and an additional $525 million in milestone payments for Kite if the company sees the successful completion of regulatory and commercialization milestones. It also has built-in single- to double-digit royalties for sales and the license of Kite's intellectual property for CAR T cell products.
January 6, 2015 - The Wall Street Journal
Salix Pharmaceuticals Ltd. said President and Chief Executive Carolyn Logan plans to retire by the end of January, months after an accounting issue may have derailed the drug maker's takeover. The departure comes after the maker of the antibiotic Xifaxan had to change its accounting last year in an indication that sales of its drugs weren't as strong as Wall Street had expected. The changes prompted a board review and were accompanied by the resignation of Chief
Financial Officer Adam Derbyshire.
January 6, 2015 - Bio Space
Belgium-based Cardio3 BioSciences, a biotechnology company focused on the development of cell therapies, announced today that it has acquired OnCyte in a $161 million deal. OnCyte is the oncology division of Celdara Medical, a privately held biotechnology company situated in the U.S. As a result of the deal, Cardio3 has positioned itself at the front of the Chimeric Antigen Receptor T-Cell space. The company will pay $10 million upfront for OnCyte, and $4 million will be paid in shares of Cardio3. "We are extremely proud of everything that the OnCyte team has accomplished to date," said Jake Reder, co-founder and CEO of Celdara Medical. "The product candidates they have developed could have a tremendous impact on the field of immuno-oncology, and we believe that Cardio3 BioSciences is the optimal partner to lead the further advancement of this groundbreaking technology. Cardio3 BioSciences possesses the right scientific, manufacturing, and clinical expertise to continue developing these therapies and to realize their full potential."
January 6, 2015 - Pharma Times
Gilead Sciences has hit the acquisition trail to acquire investigational liver disease drugs from privately-held German biotech Phenex Pharmaceuticals. Gilead is buying Phenex' farnesoid X receptor (FXR) agonists for diseases including non-alcoholic steatohepatitis (NASH). It will pay an undisclosed upfront pfee plus additional payments which may potentially be worth up to $470 million. NASH is a common, serious chronic disease characterised by inflammation and excessive fat accumulation in the liver. It may lead to progressive fibrosis, cirrhosis and liver failure and is estimated to affect 10-20% of people in the developed world. There are currently no approved therapies.
January 6, 2015 - Pharma Times
Long cited as a takeover target, rare disease specialist NPS Pharmaceuticals is seeking a buyer, according to a report in the Wall Street Journal. The newspaper reports that Goldman Sachs has started to contact companies to gauge their interest in NPS, which may be available at upwards of $4.5 billion. Shire has regularly been mentioned as a potential purchaser and is on the look-out for acquisitions having had its warchest boosted by a $1.6 billion break-up fee banked after AbbVie pulled out of a proposed merger last year.
January 6, 2015 - Bio Space
Cambridge, Mass-based gene therapy startup Moderna Therapeutics had a booming first week of 2015, announcing Monday it has raised $450 million in a new round of funding, money it will use to hire 100 new staffers, drug development experts and scientists in the coming months. Moderna said that the funding from new investors Viking Global Investors, Invus, RA Capital Management, and Wellington Management Company, as well as existing investors AstraZeneca PLC (AZN) and Alexion Pharmaceuticals Inc. (ALXN), will be used to advance its modified mRNA to create cellular "machinery" to make therapeutic proteins in vivo. Moderna has long been a poster child for Big Biotech firm AstraZeneca, with the British company so far sinking millions into its promising new field of gene therapy.
January 6, 2015 - Bio Space
Investment is continuing to pour into the Bay Area biotech community in 2015, with Global Blood Therapeutics, a biopharma that uses small molecule therapeutics for the treatment of severe blood disorders, saying Tuesday that it had closed a $48 million Series B financing-money it will use to conduct the first human trials for its experimental sickle cell disease therapy. The round included investments from Wellington Management Company, RA Capital, Deerfield Management, Sabby Capital, Perceptive Life Sciences, as well as an affiliate of Cowen Group and one undisclosed blue chip public investment fund. Biotech watchers were buzzing Tuesday about the absence of one of GBT's former investors, Third Rock Ventures, which initially helped create the company in 2012 with $40.7 million but has apparently sat out this particular round out. The company did not comment on Third Rock's abstention.
January 6, 2015 - Bio Space
Carlsbad, Calif.-based Isis Pharmaceuticals, Inc. (ISIS) announced today that it had entered into a collaboration deal with Janssen Biotech Inc. (JNJ) to partner on the discovery and development of antisense compounds to treat autoimmune disorders of the gastrointestinal (GI) tract. The news pushed the company's share price up more than 8 percent in morning trading to rest at $66.78. Isis stock has been on a gradual rise for the last month. Its Dec. 5 share price was $52.76. It has had its ups and downs since, with a high of $65.09 on Dec. 19. The deal will encompass three programs. Janssen will pay Isis $35 million in upfront payments, including a down payment to start human lead optimization on the companies' first target. Isis may also receive almost $800 million in various milestone payments and licensing fees. Tiered royalties are also pending successful commercialization.
January 6, 2015 - Pharma Times
Bristol-Myers Squibb has linked up with the California Institute for Biomedical Research to develop anti-fibrotic therapies. The US major has bagged exclusive rights to develop, manufacture and commercialise Calibr's preclinical compounds resulting from the collaboration. No financial terms have been disclosed.
January 8, 2015 - Bio Space
The field of immuno-oncology is heating up Thursday, after Cambridge, Mass.-startup Surface Oncology announced it had closed a $35 million Series A round funded by heavy-hitters including Atlas Venture, Fidelity Biosciences, New Enterprise Associates, Lilly Ventures, Amgen Ventures and the Novartis Institute for Biomedical Research (NIBR). As part of the deal, Elliott Sigal, the former head of research and development at Bristol-Myers Squibb, will now join the company's scientific advisory board (SAB). Joining the board of directors are Robert Garland, managing director and partner at NEA, Armen Shanafelt, general partner at Lilly Ventures, and Robert Weisskoff, partner at Fidelity Biosciences.
January 9, 2015 - Bio Space
Delaware-based Icyte Corporation (INCY) announced today that it has created an agreement with Agenus (AGEN), an immuno-oncology company, to focus on developing and commercializing immuno-therapeutics. Under the $445 million agreement, the companies will use Agenus' Retrocyte Display, an antibody discovery platform. Incyte will make upfront payments to Agenus for a total of $25 million and invest $35 million in purchasing 7.76 million shares of Agenus common stock. For each royalty bearing product, Agenus will be eligible to receive up to $155 million in contingent development, regulatory and commercialization milestones. "This alliance with Agenus adds therapeutic antibody capabilities to our proven small molecule discovery expertise, significantly expands the landscape of potential immuno-oncology targets available to us, and strengthens our ability to identify and advance novel therapeutic combinations," said Harve Hoppoenot, president and CEO of Incyte.
January 9, 2015 - Bio Space
The price war for pricy hepatitis C treatments took another turn today with Gilead Sciences, Inc. (GILD) signing a definitive agreement with health insurance company Anthem, Inc. Anthem has agreed that Gilead's Harvoni will be the primary treatment for genotype 1 hepatitis C, citing better pricing compared to AbbVie (ABBV)'s Viekira Pak. "We were able to achieve a very competitive rate and a freeze on retail pricing for 2015," an Anthem spokesperson said in a statement. "That does favorably impact plan costs for 2015." Both treatments are enormously expensive: Gilead's Sovaldi treatment ran around $84,000, or about $1,000 per pill. Harvoni's 12-week course of treatment cost around $94,500. Viekira Pak's price for a 12-week course of treatment is $83,310.
January 9, 2015 - Outsourcing Pharma
Horizon says its �6m (€7.7m) purchase of Austrian biotech Haplogen Genomics means it can produce cell lines ten times faster than before using a haploid gene platform.
Generics could sink AbbVie below analysts' 2015 estimates
January 9, 2015 - Fierce Pharma
On his company's Q3 conference call back in October, AbbVie CEO Richard Gonzalez told investors the pharma was in an even stronger position today than before it announced its failed $55 billion merger with Ireland's Shire ($SHPG). But with low-cost competitors ready to sink their teeth into the drugmaker's top products, 2015 adjusted earnings may miss analysts' forecasts. Earnings for the year will reach $4.25 to $4.45 a share, AbbVie ($ABBV) said Thursday. According to Bloomberg, that will hit the low end of analyst estimates that averaged $4.42.
January 9, 2015 - Fierce Biotech
Incyte ($INCY) is jumping aboard Agenus' antibody discovery platform, signing up to partner on new immuno-oncology drugs with $60 million in cash and promises of up to $350 million in milestones. And the deal news quickly drove up Agenus' ($AGEN) shares by more than 30% in premarket trading. At the heart of this deal is a slate of checkpoint regulators: GITR, OX40, LAG-3 and TIM-3. While PD-1/PD-L1 has captured the full attention of the biopharma industry and a large segment of the investment community, these four other targets also promise to play a role in a new generation of cancer therapies that has been inspiring a wave of new deals just like this. The goal is to find new ways to mix and match therapies that spur an immune system attack on various cancers. And Incyte, which is already partnered with several of the leaders in the field, is setting out to stake out some prime territory in the second wave of immuno-oncology drugs taking shape in the pipeline.
January 11, 2015 - The Wall Street Journal
Merck & Co. has accelerated its plans to submit new drugs for hepatitis C and lung cancer for regulatory approval, in a bid to close the gap with competitors in two lucrative segments. The Kenilworth, N.J., drug maker hopes that an overhaul of its research-and-development engine in the past 18 months has positioned it to introduce the new drugs at least several months earlier than expected. It is possible the drugs could hit the market later this year if government regulators approve them. Merck has made speed an important focus of its R&D overhaul, in an effort to get to market as fast as possible with new drugs. The company has cut spending on many of its research programs and shifted resources to more promising projects including cancer immunotherapy and hepatitis C. One tack to speed development: enrolling patients in clinical trials of its experimental hepatitis C treatment more quickly than originally planned. Roche Holding to Pay $1.03 Billion for Diagnostics-Firm Stake
January 11, 2015 - The Wall Street Journal
Roche Holding AG agreed to pay $1.03 billion for up to a 56.3% stake in Foundation Medicine Inc. in a collaboration that underscores the growing importance of genetic diagnostics in the treatment and development of drugs for cancer. Under the agreement, Roche will launch a tender offer for about 15.6 million shares of the Cambridge, Mass., maker of molecular diagnostic tests for about $780 million, or $50 a share, and it will also acquire five million new shares of the company, also for $50 each. The amount is a 109% premium over Foundation's closing price of $23.93 on Friday. Foundation has developed and markets two tests-one for solid tumors such as lung cancer and melanoma and one for blood cancers such as leukemia-that use next-generation genetic sequencing to identify mutations that are the drivers of a patient's disease. Doctors can use the results to try to match patients with available drugs that target the identified mutations or with clinical trials testing such drugs.
January 11, 2015 - Fierce Biotech
Bristol-Myers Squibb's ($BMY) standout immuno-oncology drug nivolumab, approved last month as Opdivo, scored a resounding success in a late-stage lung cancer trial, bolstering sales expectations for the pioneering treatment. In a 272-patient study pitting Opdivo against the standard cancer-killer docetaxel, Bristol-Myers drug demonstrated such superior overall survival compared with the control arm that it hit its primary endpoint ahead of schedule, leading the trial's data monitoring committee recommend the study be terminated early. Bristol-Myers is now inviting the patients in the docetaxel group to opt into Opdivo through an open-label extension study. Bristol-Myers' treatment is designed to galvanize an immune system attack on tumors by blocking a pathway called PD-1, which, left unchecked, allows cancer cells to pass undetected by the body's natural defenses. Like Merck's ($MRK) similar Keytruda, Opdivo won FDA approval last year as a treatment for melanoma, but Bristol-Myers' drug stands alone in lung cancer, as its latest clinical success marks the first time a PD-1 inhibitor has charted a survival advantage against the disease, the company said.
January 11, 2015 - Fierce Biotech
Back last summer the UK's Convergence Pharmaceuticals, a spinout from GlaxoSmithKline, was feeling bullish about its prospects after it wrapped up a positive mid-stage study of its lead drug for neuropathic pain. But rather than take the risky step of mounting an IPO - still a tough prospect in the UK - Convergence instead opted to sell to Biogen Idec, which is using the acquisition to beef up its pipeline in the field. Biogen on Sunday said that it had agreed to pay $200 million in an upfront cash payment to Convergence's investors, promising up to $475 million more in milestones if the drug continues to look promising in clinical studies. The deal gives Biogen Idec CNV1014802 and a portfolio of ion channel-modulating drugs. And you can chalk up another biotech deal story to the frenzied news pace that surrounds this year's JP Morgan event in San Francisco.
