Ceftazidime/avibactam meets in cIAI trials
AstraZeneca plc (LSE:AZN; NYSE:AZN) and Actavis plc (NYSE:ACT) said IV ceftazidime/avibactam (CAZ-104) plus metronidazole met the EMA- and FDA-defined primary endpoints of non-inferiority to meropenem in pooled data from the identical Phase III RECLAIM-1 and RECLAIM-2 trials to treat complicated intra-abdominal infections (cIAIs). The EMA-defined co-primary endpoints were non-inferiority in improving the clinical cure rate at test-of-cure visit in both the modified-intent-to-treat (MITT) and clinically evaluable patient populations. The FDA-defined primary endpoint was non-inferiority in improving clinical cure rate at the test-of-cure visit in the microbiological MITT population.
AMG 416 meets in second secondary hyperparathyroidism trial
Amgen Inc. (NASDAQ:AMGN) said IV AMG 416 met the primary endpoint vs. placebo in the 508-patient Phase III 20120229 trial to treat secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis. AMG 416 given thrice weekly for 26 weeks led to a greater proportion of patients with a greater than 30% reduction from baseline in parathyroid hormone (PTH) levels during weeks 20-27 (74% for AMG 416 vs. 8.3% for placebo, p-value not disclosed). All patients also received standard of care.
Oncothyreon slides on tecemotide Japanese trial miss
Oncothyreon Inc. (NASDAQ:ONTY) slid $0.48 (17%) to $2.30 on Tuesday after disclosing in an SEC filing that partner Merck KGaA (Xetra:MRK) said tecemotide (L-BLP25) missed the primary overall survival (OS) endpoint vs. placebo in a 178-patient, Japanese Phase I/II trial to treat non-small cell lung cancer (NSCLC). The majority of patients received concurrent chemoradiotherapy. According to Oncothyreon, Merck said it "will review the implications" of the data for the ongoing tecemotide program.
Tentative FDA approval for Lilly, Boehringer insulin glargine
FDA granted tentative approval to Basaglar insulin glargine (LY2963016) from Eli Lilly and Co. (NYSE:LLY) and Boehringer Ingelheim GmbH (Ingelheim, Germany) to treat Type I and Type II diabetes. The tentative approval is based in part on data from two open-label Phase III trials showing once-daily Basaglar -- a basal insulin analog -- met the primary endpoint of non-inferiority to once-daily Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY) in reducing HbA1c from baseline to week 24 (see BioCentury Extra, June 16).
FDA accepts Boehringer tiotropium/olodaterol NDA
Boehringer Ingelheim GmbH (Ingelheim, Germany) said FDA accepted for review an NDA for a once-daily, fixed-dose combination of tiotropium/olodaterol delivered via the company's Respimat soft mist inhaler to treat chronic obstructive pulmonary disorder (COPD). Boehringer could not be reached for a PDUFA date.
FDA approves Genzyme's Cerdelga
FDA approved Cerdelga eliglustat from the Genzyme Corp. unit of Sanofi (Euronext:SAN; NYSE:SNY) to treat Type I Gaucher's disease. The product is also under review in Europe for the indication. Genzyme said it plans to launch the oral ceramide analog that inhibits glucosylceramide synthase (GCS) in the U.S. within a month. The company also said Cerdelga's price will "be on par" with the pricing for Cerezyme imiglucerase, an enzyme replacement therapy that Genzyme already markets for Type I Gaucher's. According to Genzyme, the average annual cost in the U.S. for Cerezyme -- a recombinant glucocerebrosidase administered as an IV infusion -- is about $300,000.
Salix jumps on rumored Allergan bid
Gastrointestinal company Salix Pharmaceuticals Ltd. (NASDAQ:SLXP) jumped $21.63 (16%) to $160.80 on Tuesday on media reports that Allergan Inc. (NYSE:AGN) approached Salix regarding an acquisition offer. According to the Wall Street Journal, Allergan approached Salix and at least one other company about a potential acquisition, as it fends off a hostile takeover from Valeant Pharmaceuticals International Inc. (TSX:VRX; NYSE:VRX). Allergan declined to comment on the rumors, and Salix could not be reached. Allergan was up $6.21 to $161.82 on Tuesday.
Emergent, MorphoSys to co-develop MOR209/ES414
MorphoSys AG (Xetra:MOR; Pink:MPSYF) partnered with Emergent BioSolutions Inc. (NYSE:EBS) to develop and commercialize ES414, a bispecific ADAPTIR antibody targeting prostate-specific membrane antigen (PSMA; FOLH1; GCPII) and CD3. The compound -- to be renamed MOR209/ES414 -- was shown in preclinical studies to cause T cells to attack prostate cancer cells expressing PSMA.
Evotec, MMV providing researchers compounds free of charge
Evotec AG (Xetra:EVT) will use its compound management services to support the Malaria and Pathogen Box initiatives from Medicines for Malaria Venture, through which the not-for-profit provides researchers molecules to study free of charge. The Malaria Box, which is already available, contains 400 molecules against blood stage Plasmodium falciparum. MMV is still selecting molecules for the similarly sized Pathogen Box for malaria and a range of neglected diseases. The group expects to make the Pathogen Box available starting in 4Q15. On its website, Evotec says its services include high throughput compound analysis, inert atmosphere and low temperature storage and processing, and worldwide delivery.
Novartis buying Gamida stake, gains option to acquire
Novartis AG (NYSE:NVS; SIX:NOVN) will pay $35 million to acquire a 15% equity stake in Gamida Cell Ltd. (Jerusalem, Israel) and an option to acquire the Israeli biotech for $165 million in cash and up to $435 million in milestones. Novartis' option is exercisable following undisclosed milestones related to Gamida's NiCord, which Gamida expects to meet next year. NiCord comprises ex vivo nicotinamide-expanded hematopoietic stem and progenitor cells that are derived from umbilical cord blood. The product is in Phase I/II testing to treat hematologic malignancies, with a Phase III trial slated to start by the end of 2015.
HealthQuest raises $110M for initial fund
HealthQuest Capital raised $110 million for its debut fund, more than doubling its initial $50 million target. The fund will invest in the medical device, diagnostic, patient care product, consumer health/OTC and healthcare IT fields with a focus on commercial-stage investments. HealthQuest will typically make an initial investment of $2-$4 million per company with a total investment as high as $7-$10 million over each portfolio company's lifespan. HealthQuest has already made three investments from the fund, including one in cancer diagnostic company Castle Biosciences Inc. (Friendswood, Texas).
Dermatology play Dermira raises $51 million in series C
Dermira Inc. (Redwood City, Calif.) raised $51 million in a series C round and announced a number of management changes and board appointments. The C round came from existing investors Bay City Capital; New Enterprise Associates; Canaan Partners; and UCB Group (Euronext:UCB). New investors Apple Tree Partners; Aisling Capital; Rock Springs Capital; Sabby Capital; and other undisclosed healthcare investors also participated.
POLITICS & POLICY
Sanford-Burnham names Nisen CEO
Sanford-Burnham Medical Research Institute named Perry Nisen CEO, effective Sept. 15. Nisen was SVP of science and innovation at GlaxoSmithKline plc (LSE:GSK; NYSE:GSK). He replaces John Reed, who joined Roche (SIX:ROG; OTCQX:RHHBY) in January 2013. Sanford-Burnham President Kristiina Vuori served as interim CEO of the institute.