Deals and Data, 2/3/09: Cypress, Ferring and Ligand all get FDA Approvals in Drug Discovery Hat Trick
Starting the year off with a bang, Cypress Bioscience and partner Forest Labs got the great news of an FDA approval for the company's treatment for fibromyalgia which is now called Savella. Shares in Cypress skyrocketed 66 percent on the news, which marks Cypress's first product which will be used to treat chronic pain associated with the condition. Here's a story on the background of the company and drug from the Union-Tribune.
Ferring Research, the Torrey Pines-based research division of Ferring Pharmaceuticals, discovered a peptide now called degarelix that was approved by the US Food and Drug Administration on Christmas Eve, a week after it was approved in Europe. The drug, one of five in development that were discovered in Torrey Pines, is to treat advanced prostate cancer, and will mark Ferring's first global product launch.
And to round out Southern California's drug discovery hat trick, don't forget that Ligand Pharmaceuticals just landed an approval for Promacta, a drug it discovered and GlaxoSmithKline developed. Keeping up the good work, Ligand Pharmaceuticals says it signed another exclusive deal with GSK, this time over its LGD-4665, a next generation version of Promacta. LGD-4665 is in Phase II for treatment of thrombocytopenia, a condition of low-platelet levels associated with a several clinical disorders. GlaxoSmithKline will pay Ligand $5 million upfront, up to $158 million in development and commercial milestones and a 16 percent royalty on net sales. Ligand just finished its acquisition of Pharmacopeia and subsequently made some changes on its board.
Isis Pharmaceuticals has continued on its roll, this time selling off its Ibis subsidiary to big-pharma firm Abbott for $175 million. Abbott plans on using the Ibis technology in larger commercial markets for clinical diagnostics and infectious disease detection. Isis and partner Genzyme also launched new trials of its Mipomersen in hypercholesterolemia.
La Jolla Pharmaceuticals beefed up its balance sheet with a major partnership on its lupus drug Riquent with Bay Area-based BioMarin Pharmaceuticals. La Jolla could receive up to $289 million in cash, with $15 million upfront, $92.5 million related to clinical milestones, $55 million for regulatory milestones, and up to $126 million for achieving specified annual net sales milestones beginning at $250 million in sales.
NuVasive is keeping up the pace, taking home a $5 million payment from Osiris, raising their sales outlook for 2009, and investing in an orthobiologics company. What's that you say? Progentix Orthobiology BV is a Netherlands based company with a synthetic bone substitute technology designed to accelerate bone healing, marking marks NuVasive's third strategic transaction in the biologics arena.
Rumor has it Anaphore landed a $25 million venture financing from 5AM; Versant and Apposite Capital … and word on the street is that Axikin Pharmaceuticalstook home a $3 million venture financing from Sanderling and Mitsui Venture. Now since these rumor were in BioCentury, we're taking it as the truth.
Gen-Probe says it will pay $132 million for Tepnel Life Sciences, PLC, a molecular diagnostics company based in the United Kingdom that does testing to match donors and recipients in anticipation of transplant surgeries, as well as in the ongoing management of transplant recipients.
Volcano acquired Axsun Technologies for $21.5 million. Axsun makes lasers and optical engines used in medical Optical Coherence Tomography (OCT) imaging systems and advanced photonic components for industrial applications.
Shares of Anadys Pharmaceuticals skyrocketed more than 100 percent on strong Phase IIb data of its ANA598 antiviral to treat Hepatitis C … Victory Pharma launched two new dosage strengths of Naprelan Controlled-Release Tablets, a once-daily, controlled-release formulation of naproxen sodium, a non-steroidal anti-inflammatory drug indicated for the treatment of a number of conditions, including osteoarthritis, rheumatoid arthritis and management of mild to moderate pain.
Trius Pharmaceuticals, recently named by BusinessWeek as one of last year's most successful startups, completed its Phase II trial of a new skin infection treatment.
Xconomy.com notes that former SGX Pharmaceuticals CEO Michael Grey was named president and CEO of Auspex Pharmaceuticals, a Vista-based biotech founded in 2001 to develop next-generation medicines with improved performance. While you are in that net neighborhood, Xconomy.com profiled CalciMedica here and wrote an interesting profile of Enterprise Partners here.
The Burnham Institute singed a partnership with Johnson & Johnson, you can read all about that here … Novocell forged a non-exclusive drug discovery deal giving Pfizer access to Novocell's pancreatic progenitor cells derived from human embryonic stem cells. Read the release here … Acadia Pharmaceuticals took home a $830,000 grant from the Michael J. Fox Foundation to work on a treatment for Parkinson's disease.
Amira Pharmaceuticals said its AM211 for inflammatory and allergic diseases is on target for submission of an IND to the U.S. Food and Drug Administration by mid-2009 following successful early toxicity studies … SkinMedica launched a new Web site for physicians as well as launched a new line of acne washes …
Life Technologies, the Carlsbad-based combination of Applied Biosystems and Invitrogen with 10,000 employees, launched a slew of scientific products, including a bench-top protein analysis system, new media for embryonic stem cell cultures, a CSI-sounding Forensic DNA Extraction kit for criminal investigations and received approval from Canada to use its analysis system to determine organ donor compatibility.
Diagnostics firm Quidel took just two weeks to name Douglas Bryant as president and chief executive officer. Bryant has experience at Luminex Corporation and Abbott Laboratories. Current CEO Caren Mason will be retiring after four years in June.
Cadence Pharmaceuticals showed strong Phase III data of its intravenous aspirin formulation for pain … Cytori Therapeutics started a study to look at using its adult stem cell harvesting technology to treat chronic radiation injury, and signed a commercialization partnership with GE Healthcare that is sure to bring sales to life.
Orexigen Therapeutics says its Contrave showed a significant weight loss in a Phase III clinical trial; the company is conducting continued research on the drug.
Cylene Pharmaceuticals says it started a Phase I trial of a treatment for patients with advanced solid tumors, Castleman's disease, or multiple myeloma … Halozyme Therapeutics said it started a Phase I trial of its second biologic with partner Roche, as well as presented preclinical data on a cancer treatment.
Tragara Pharmaceuticals will spend up to $112.5 million upfront fees, development and sales milestone payments and up to double-digit royalties for S*BIO's novel multi-kinase inhibitor SB1317 to treat solid tumors.
Adventrx is exploring its options after downsizing … Pacira Pharmaceuticals, based in New Jersey but with a facility in Torrey Pines, says its pain treatment was effective at treating pain from hernia surgery in a Phase II trial … Ardea Biosciences became the first biotech in more than two months to pull in a private placement north of $30 million with this $30.6 million private placement. Areda is working on small-molecule therapeutics to treat HIV, gout, cancer and inflammatory diseases.
Acquisitions aren’t always an exact science. Just ask Sequenom, one of the best performing stocks of 2008, who made a $41 million play for Exact Sciences. Exact Sciences said no, so Sequenom went out and bought a portfolio of tests from SensiGen, who has been developing advanced gene-based molecular tests under a partnership agreement with Sequenom. Sensigen makes tests for detection and monitoring of human papillomavirus -- the primary cause of cervical and head and neck cancers, Lupus, chronic kidney disease, inflammatory bowel disease, as well as other tests, all of which utilize Sequenom’s MassARRAY platform. Sequenom will also work with UCSF on a screening test for severe combined immunodeficiency in infants, and demonstrated more great data on its down syndrome test.
'Twas the night before the night before Christmas when MedicNova made a move to buy Avigen. Financial terms weren't disclosed but apparently they weren’t enough, with shareholder BVF Acquisition is trying to make the deal happen for $20.9 million … Likewise, Nanogen says its planned acquisition of Elitech isn't likely to close.
On actual Christmas Eve, Ista Pharmaceuticals got the present of a credit line extended to $25 million from $10 million, courtesy of Silicon Valley Bank. Ista also had a drug application for a conjunctiva eye drop accepted for review by the FDA as well as demonstrated positive Phase IIb data on ecabet sodium, which is being developed as a treatment for dry eye disease.
Nerveda Inc. and Aegis Therapeutics showed preclinical results from their joint collaboration on non-injectable formulations of the beta-interferons, closely related to injectable protein drugs in the interferon family that are used to treat both the relapsing-remitting and secondary-progressive forms of multiple sclerosis (MS). More info here (PDF).
International Stem Cells says it lined up $5 million in funding and has taken the first million and started a pre-clinical trial for a new stem-cell based treatment for retinal diseases … Nexbio completed its first-in-man clinical trial of DAS181, Fludase, to treat influenza … Meritage Pharma started a Phase 2b clinical trial to evaluate oral viscous budesonide for the treatment of children and adolescents with eosinophilic esophagitis, an inflammatory allergy of the esophagus.
BIOCOM hosted a monthly breakfast with Jay Lichter of San Diego’s Avalon Ventures, David Kabakoff, an executive-in-residence in the San Diego office of Soffinova Ventures in BIOCOM’s Executive VC Suite and Stan Fleming, a co-founder and managing member of San Diego’s Forward Ventures. Please click here to read articles in Xconomy.com about the breakfast and this piece in the San Diego Daily Transcript.
DSM Biologics, a business unit of DSM Pharmaceutical Products, and Dutch biopharmaceutical company Crucell N.V. said that GlaxoSmithKline signed a license agreement allowing GSK to research a recombinant protein on the company's PER.C6 platform for large-scale manufacture of biopharmaceutical products such as recombinant proteins including monoclonal antibodies. Financial terms of the agreement were not disclosed.
And in Orange County, Spectrum Pharmaceuticals and partner Cell Therapeutics demonstrated an 83 percent response rate with its drug Zevalin to treat lymphoma, while its Fusilev was listed as part of a standard drug combo for bone cancer. And finally, Cortex Pharmaceuticals says it will launch a clinical study of a new sleep apnea treatment.