May 4, 2015 - Bio Space

Carlsbad, Calif.-based Isis Pharmaceuticals, Inc. inked a $155 million deal with Bayer HealthCare to develop and market ISIS-FXIRx, a treatment and preventative for thrombosis. The deal is structured so that Isis will receive an upfront payment of $100 million, with another $55 million when the program moves out of a Phase II study. Additional milestone payments are included, as well as tiered royalties. Bayer will take on global clinical development, as well as global regulatory and commercialization responsibilities. ISIS-FXIRx targets Factor XI, a chemical produced by the liver that is a major component in blood clotting. Individuals with high levels of Factor XI are at increased risk of heart attacks and strokes. In a Phase II trial, patients treated with ISIS-FSIRx had a seven-fold lower rate of venous thromboembolic events (VTEs) than patients treated with enoxaparin.

May 4, 2015 - The Wall Street Journal

Generic Vicodin's ranking as the drug most widely prescribed to Medicare beneficiaries in 2013 illustrates how comfortable doctors have become reaching for this powerful painkiller for primary care, despite its potential for abuse. An analysis of data released last week on Medicare's prescription-drug program found that more than half of the prescriptions for the drug, known generically as hydrocodone acetaminophen, came from family-practice or internal-medicine physicians. Those two specialties represented just under a quarter of the more than one million providers in the data. Researchers said the findings reflect the years-long increase in the use of opioid painkillers in the U.S., which comes in tandem with concerns about abuse. According to the Centers for Disease Control and Prevention, nearly two million Americans either abused or were dependent on opioids in 2013. "It's striking that the drug prescribed to the most beneficiaries is a narcotic painkiller that can be addictive," said Walid Gellad, an associate professor at the University of Pittsburgh School of Medicine.

May 4, 2015 - Pharmaceutical Business Review

Sorrento Therapeutics' fully owned subsidiary, Igdrasol, has acquired exclusive distribution rights to Cynviloq in South America from South Korean firm Samyang Biopharmaceuticals (Samyang). Cynviloq, which is marketed as Genexol-PM in South Korea, is the company's next-generation nanoparticle paclitaxel and it completed patient enrollment in the Tribeca registrational trial in January. Sorrento, oncology firm developing new treatments for cancer and associated pain, is also developing resiniferatoxin (RTX), a non-opiate TRPV1 agonist currently in a Phase I/II trial at the NIH to treat terminal cancer patients suffering from intractable pain.

May 4, 2015 - Pharmaceutical Business Review

Japanese biopharmaceutical firm PeptiDream has entered into a multi-target discovery and optimization collaboration with US-based Merck for the development of peptides. Under the deal, PeptiDream will use its peptide discovery platform system (PDPS) technology to produce macrocylic/constrained peptides against multiple targets of interest selected by Merck. Merck will have the right to develop and commercialize all therapeutic peptides resulting from the collaboration and will also retain an option to nonexclusively license the PDPS technology in the future.

Alder hunts for a new partner after Bristol-Myers nixed a $1B deal 

May 5, 2015 - Fierce Biotech

Alder BioPharmaceuticals is touting more mid-stage success for its in-development inflammation treatment, scouting for a deep-pocketed partner to pick up where ex-collaborator Bristol-Myers Squibb left off. The antibody, clazakizumab, met its primary endpoint in a Phase IIb study in rheumatoid arthritis, Alder said, following promising mid-stage data in migraine. The company believes its candidate, an interleukin-6 inhibitor, could have a bright future in Phase III, and the latest data "provide additional support for the promise of clazakizumab as we seek a new partner to continue developing this monoclonal antibody for the treatment of autoimmune and inflammatory diseases," CEO Randall Schatzman said in a statement. Bristol-Myers licensed the treatment back in 2009, signing a deal worth up to $1 billion, but the drugmaker backed out last fall amid a widespread pipeline re-evaluation.

May 5, 2015 - Bio Space

White-hot venture capital and venture creation firm Flagship Ventures is having a stellar week, saying Tuesday it has formed three new strategic partnerships with AstraZeneca PLC, Nestlé Health Science and Bayer CropScience, as a raging biotech sector continues to roar. Flagship, which manages $1.4 billion in capital, is perhaps best known for the eight successful IPOs it HAS backed in the past two years, as well as the formation of 27 companies to date. The new partnerships also include an investment in Flagship Ventures Fund V, a $537 million venture capital fund that closed in March 2015. Bayer CropScience will now team up with Flagship to identify, fund and develop startup companies exploring new frontiers in agriculture.

May 5, 2015 - Device Space

Medtronic plc today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance and U.S. launch of the Euphora(TM) Semicompliant Balloon Dilatation Catheter, a pre-dilatation therapy used during a stent implantation to reopen a narrowed coronary artery caused by plaque buildup. The first patient case with the Euphora Semicompliant Balloon Catheter was recently performed by James T. DeVries, MD, FACC, FSCAI, director of Endovascular Intervention and associate director of the Cardiac Catheterization Lab at Dartmouth-Hitchcock Medical Center in Lebanon, NH. "We at Dartmouth-Hitchcock Medical Center are pleased to have been chosen as the U.S. launch site for the Medtronic Euphora balloon," said DeVries. "This continued access to new technology is essential to help our patients in the ongoing battle against coronary artery disease."

May 6, 2015 - Pharma Times

The mood for mega deals in the pharmaceuticals sector shows no sign of abating, as Alexion unveils plans to buy Synageva BioPharma for a whopping $8.4 billion. The move sees Alexion, which currently has just one drug - the hugely expensive Soliris (eculizumab) - on the market, delve much deeper into the rare diseases field, an increasingly popular target for bolstering R&D pipelines as the blockbuster era recedes into the distance. Alexion has laid on the table $115 in cash and 0.6581 of its shares, equating to around $230 per Synageva share, which is more than twice its current value. But "while some investors may be picking their jaws off the floor at such a valuation, we note that Synageva has only disclosed a fraction of its development efforts," noted Baird Equity Research analyst Christopher Raymond, according to Reuters.

May 6, 2015 - Pharma Times

Teva has completed its $3.5-billion purchase of Auspex Pharmaceuticals, in a move the Israeli drugmaker says will enhance its revenue and earnings growth profile and strengthen its core central nervous system franchise. The moves gives the firm access to Auspex' lead investigational product SD-809 (Teva has completed its $3.5-billion purchase of Auspex Pharmaceuticals, in a move the Israeli drugmaker says will enhance its revenue and earnings growth profile and strengthen its core central nervous system franchise.

May 6, 2015 - Bio Space

British biopharma company Kymab has raised $50 million in a Series B round that is the final portion of $90 million financing, the company said Wednesday, and will use the money to develop its antibody-generating technology, Kymouse. The final $50 million has been a long time coming--the Bill & Melinda Gates Foundation and The Wellcome Trust and ponied up the initial $40 million last May. Today's investment is primarily from two companies under the aegis of legendary British investor Neil Woodford, Malin Corp and Woodford Patient Capital Trust. "We are delighted to welcome high quality investors of the caliber of Malin and Woodford to Kymab which support our goal to build Kymab into a sustainable biopharmaceutical company," said David Chiswell, chairman and interim CEO of Kymab, in a statement. "The funds will be used to maximize the potential of the Kymab pipeline as we develop and commercialize monoclonal antibody medicines for difficult and novel drug targets."

May 6, 2015 - Bio Space

Newark, NJ-based Symbiomix is finally hitting the big time, announcing Wednesday that it has snagged $41 million in a Series A round from marquee-name investors, while successfully navigating a Phase II trial of its main drug candidate. That money will be used to fund a Phase III trial as soon as the second quarter, said the company. Investors included OrbiMed, Fidelity BioSciences, HBM Partners and Square 1 Bank. It now says that antibiotic, SYM-1219 for the treatment of bacterial vaginosis, will roll right into a Phase III trial by the second quarter of 2015.

May 6, 2015 - Device Space

EndoChoice today announced that it has filed a registration statement on Form S-1 with the Securities and Exchange Commission relating to the proposed initial public offering of its common stock. The proposed public offering is expected to consist of common stock offered by EndoChoice. The number of shares to be sold and the price range for the proposed offering have not yet been determined. EndoChoice intends to apply to list its common stock on The New York Stock Exchange under the ticker symbol "GI". J.P. Morgan and BofA Merrill Lynch are acting as joint lead book-running managers for the proposed offering. William Blair and Stifel are acting as co-managers for the proposed offering.

J&J Changes Compassionate Care

May 7, 2015 - The Wall Street Journal

Under increasing pressure to expand access to experimental medicines, Johnson & Johnson has arranged for an independent panel to review requests from seriously ill patients who want to try an unapproved drug even if they aren't participating in the drug's testing. The committee of doctors, bioethicists and patient representatives organized by the New York University School of Medicine will consider the hundreds of requests that J&J receives each year from patients who believe an experimental drug can help them. The panel will recommend a course of action to J&J. Until now, the decisions have been largely left in the hands of individual physicians around the company working on particular drugs. "This really assures each request is handled in an objective and thoughtful manner," said J&J Chief Medical Officer Joanne Waldstreicher.

Gilead shells out $65m on EpiTherapeutics 

May 7, 2015 - Pharma Times

Gilead is stepping into the field of epigenetics with a $65-million purchase of private Danish group EpiTherapeutics. Epigenetics is the study of changes in gene expression caused by factors other than alterations to the underlying DNA sequence. EpiTherapeutics has built a library of first-in-class, selective small molecule inhibitors of epigenetic regulation of gene transcription, with lead preclinical compounds currently being studied in certain cancers.

May 7, 2015 - Fierce Biotech

Biotech's protracted IPO boom has waxed and waned after a record-setting 2014, but the window stayed open long enough for three more emerging drug developers to pocket a combined $200 million. Collegium Pharmaceuticals, aTyr Pharma and CoLucid Pharmaceuticals all made their way to Wall Street amid a busy week for biotech debuts. San Diego's aTyr raised $75 million in its IPO, pricing about 5.4 million shares at $14 each, the midpoint of its expected range. The company, at work on a drug for the rare facioscapulohumeral muscular dystrophy, set aside another 804,000 shares for its underwriters to cover over-allotments, setting its maximum deal value at more than $86 million. Collegium, developing an abuse-deterrent take on oxycodone, raised $70 million by offering 5.8 million shares at $12 apiece, hitting the low end of its range. The company's extra options set it up for as much as $80 million, funds that would help it advance Xtampza ER through the FDA process and onto the market.

May 7, 2015 - Fierce Biotech

Vertex Pharmaceuticals has made a major difference--and a lot of money--in cystic fibrosis with its targeted treatments, drugs tailored for patients with particular genetic defects. But upstart Spyryx Biosciences believes it may have discovered a way to treat all forms of CF with a single therapy, and the company raised $18 million in Series A cash to advance the idea. Founded in 2013, Spyryx is fleshing out the work of University of North Carolina professor Robert Tarran, who discovered a link between the regulatory protein SPLUNC1 and the airway dehydration that causes CF's deadly pulmonary symptoms. The body uses SPLUNC1 to modulate how much fluid is absorbed in the airways, and, crafting a peptide therapy that mimics the protein's effects, Spyryx believes it has hit upon a new way to reverse CF's characteristic dehydration.

May 7, 2015 - Device Space

Ceterix® Orthopaedics today announced that it has entered into a term loan agreement with CRG and certain of its affiliate funds, providing Ceterix with up to $35 million of available borrowing capacity. "We are excited have further support to continue our mission to save the meniscus and improve the lives of patients suffering from knee injuries," said John McCutcheon, president and CEO of Ceterix Orthopaedics. "This flexible financing will allow us to continue expanding the possibilities of meniscus repair through additional investment in innovation and clinical research." "CRG is dedicated to providing growth capital to innovative commercial-stage healthcare companies," said Charles Tate, Chairman of CRG. "We are excited to partner with Ceterix as the company continues to advance its new technologies and improve patient outcomes in the meniscal surgery space."

Cancer Genetics enters into research collaboration with Moffitt Cancer Center  

May 7, 2015 - Pharmaceutical Business Review

Cancer Genetics, an emerging leader in DNA-based cancer diagnostics, announced that it has entered into a series of collaborative studies with leading researchers at Moffitt Cancer Center in Tampa, Florida. The studies, led by Moffitt researchers Heather Jim, PhD, Diane Portman, MD, Howard McLeod, PharmD, and Gillian Bell, PharmD will examine a number of genetic variants as predictors for the most common side effects associated with chemotherapy treatment. Chemotherapy-induced nausea and vomiting (CINV) is a significant clinical challenge experienced by over 50% of patients receiving chemotherapy, even when general-purpose prophylactic anti-emetic therapies are prescribed according to clinical guidelines.