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.
The MITT population was defined as patients who received at least one dose of ceftazidime/avibactam, and the microbiological MITT population comprised MITT patients who had a detectable bacterial infection at baseline. The clinically evaluable population included all patients who completed treatment per protocol. The trials enrolled a combined 1,066 patients.
In 1Q15, AstraZeneca plans to submit an MAA to EMA for ceftazidime/avibactam, but declined to disclose details. According to the pharma, RECLAIM-1 and RECLAIM-2 could form the basis of regulatory applications for a broader range of indications. Ceftazidime/avibactam -- a broad spectrum beta lactamase (LACTB) inhibitor combined with ceftazidime, a third-generation cephalosporin -- is also in Phase III testing for complicated urinary tract infections (cUTIs) and nosocomial pneumonia.
Actavis said it expects to "be in a position to announce" FDA acceptance of an NDA for the product later this quarter. The company gained rights to the product through its acquisition of Forest Laboratories Inc. Actavis was up $5.01 to $223.08 on Tuesday.
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.
Last month, Amgen said AMG 416 -- a peptide calcimimetic that acts on the parathyroid gland to reduce production of PTH -- met the same primary endpoint in the nearly identical Phase III 20120230 trial. Data from a Phase III trial comparing AMG 416 to the company's cinacalcet are expected next year. Amgen markets cinacalcet, a second-generation calcimimetic, as Mimpara in the EU and as Sensipar in the U.S. (see BioCentury Extra, July 17).
Amgen was off $0.20 to $133.02 on Tuesday.
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.
Earlier this year, the pharma started the Phase III START2 trial to evaluate tecemotide with concurrent chemoradiotherapy to treat unresectable, locally advanced NSCLC. Tecemotide is also in the similar Phase III INSPIRE trial in unresectable stage III NSCLC patients in China, Hong Kong, Korea, Singapore and Taiwan. The START2 trial came after Merck said tecemotide improved OS in a predefined subgroup of patients who received concurrent chemoradiotherapy in the Phase III START trial, despite missing the primary OS endpoint in the overall population of NSCLC patients with unresectable, locally advanced disease.
Merck has exclusive, worldwide rights to tecemotide -- a liposomal vaccine containing a synthetic 25 amino acid peptide sequence from mucin (MUC1; CD227) -- from Oncothyreon.
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).
The application was reviewed under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products. According to Lilly, Basaglar has the same amino acid sequence as Lantus.In the EU, the compound is being evaluated through EMA's biosimilar pathway. In June, EMA's CHMP backed approval of Basaglar under the name Abasria (see BioCentury Extra, June 27).
In January, Sanofi filed suit in the U.S. District Court for the District of Delaware alleging Basaglar infringes Sanofi U.S. patents covering insulin glargine formulations and pen injector devices. Sanofi filed a second suit last month. As a result of the ongoing litigation, the earliest Basaglar could get full FDA approval is mid-2016. The latest patent at issue in the suits expires in March 2024.
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.
Both tiotropium, a long-acting muscarinic antagonist (LAMA), and olodaterol, a long-acting beta 2 agonist (LABA), are already approved as monotherapies in the U.S. to treat COPD. Olodaterol as monotherapy is approved when delivered via Respimat. Tiotropium as monotherapy is approved when delivered via Boehringer's HandiHaler dry powder inhaler. An NDA for tiotropium monotherapy delivered via Respimat is under FDA review, with an undisclosed PDUFA date (see BioCentury Extra, Aug. 14).
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.
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.
Last Friday, Valeant disclosed in an SEC filing that it extended the expiration of its hostile tender offer for Allergan from Aug. 15 to Dec. 31. Valeant launched the hostile tender offer in June after Allergan's board rejected two prior bids (see BioCentury Extra, June 18).
Salix is merging with an Irish subsidiary of partner Cosmo Pharmaceuticals S.p.A. (SIX:COPN) in a stock deal slated to close next quarter. Salix announced on Tuesday that the U.S. Federal Trade Commission granted early termination of the Hart-Scott-Rodino waiting period for the proposed merger (see BioCentury Extra, July 9).
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.
The companies will jointly develop the compound with MorphoSys bearing 64% and Emergent 36% of the total costs. MorphoSys will gain worldwide commercialization rights excluding the U.S. and Canada, where Emergent will retain rights. Emergent will receive an upfront payment of $20 million and is eligible for up to $163 million in milestone payments. Emergent will receive low single digit royalties on product sales in MorphoSys's territories, and MorphoSys will receive tiered royalties from mid-single digits up to 20% on product sales in Emergent's territories.
Emergent closed up $0.32 to $23.44 and MorphoSys closed up EUR 0.62 to EUR 70.13 on Tuesday.
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.
Under the MMV initiatives, researchers are expected to share their findings and data in a scientific publication or publicly accessible database within two years of generating data. The compounds are being acquired from a mix of commercial suppliers and MMV collaborators who synthesize molecules. As of Tuesday, more than 160 Malaria boxes have been sent to 27 countries. The biotech declined to disclose financial details, while MMV could not be reached.
Evotec was off EUR 0.05 to EUR 3.67 on Tuesday.
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.
In March, Novartis and Gamida declined to comment on rumors in the Israeli media that Novartis was in "advanced talks" to acquire Gamida for up to $600 million (see BioCentury Extra, March 18).
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).
The firm describes Sofinnova Ventures, with which it shares an office and some personnel, as its sponsor. HealthQuest declined to name the LPs in the fund and would not say whether Sofinnova Ventures is among them.
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.
Dermira's lead internal program is DRM04, a topical small molecule anticholinergic that is in Phase IIb testing to treat hyperhidrosis (excessive sweating). In July, Dermira gained exclusive rights to develop UCB's autoimmune drug Cimzia certolizumab pegol for psoriasis in the U.S., Canada and the EU. The pegylated humanized antibody fragment against TNF alpha has completed Phase II testing for the indication (see BioCentury Extra, July 3).
Additionally, Dermira hired Andrew Guggenhime, former CFO of CardioDx Inc. (Palo Alto, Calif.), as CFO and COO, and Christine Conroy as SVP of regulatory affairs, formerly SVP of regulatory affairs and QA at Affymax Inc. (OTCQB:AFFY). The company also expanded its board to add four new directors, including Mark McDade, EVP of established brands, solutions and supply at UCB; and William Ringo, a senior advisor to Barclays Healthcare Group.
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.
In January, Sanford-Burnham said it received an anonymous $275 million gift to fund a new 10-year strategic plan that includes closer collaboration with pharmas to spur drug discovery and development. Nisen named epigenetics, metabolism and immunomodulation as areas of interest for the institute. The incoming CEO said he wants Sanford-Burnham to "fill the gap" between pharma and translational medicine (see SciBX: Science-Business eXchange, June 5).