Today - Monday, November 24, 2014
- Nano cap Aethlon Medical (OTCQB:AEMD +31.8%) jumps on turnover of 22M. Shares are up almost seven-fold from mid-September and still haven't breached $0.70.
- The company recently reported successful results with its Hemopurifier bio-filtration device on an Ebola patient.
- Previously: Aethlon Medical up on successful Ebola treatment
- Thinly-traded nano cap Ocera Therapeutics (OCRX +15%) rises on a 10x surge in volume albeit on turnover of only 300K. Shares have jumped 25% over the last two trading days but are still down 66% from the 52-week peak of $19.94 on January 16.
- The only recent news was an upgrade by Zacks to "outperform" with a $6.50 price target on November 19.
- Ocera's lead product is OCR-002, an ammonia scavenger being investigated for the treatment of hepatic encephalopathy, currently in Phase 2 development.
- The FDA designates Insys Therapeutics' (INSY +0.7%) pharmaceutical cannabidiol an Orphan Drug for the treatment of pediatric schizophrenia. This is the fifth such designation for the company's CBD program.
- Among the benefits of the Orphan Drug label is a seven-year period of market exclusivity if approved.
- PerkinElmer (PKI -0.3%) acquires Stockholm-based Perten Instruments Group AB for $266M. Perten manufactures advanced analytical instruments for quality control of food, grain, flour and feed. The transaction expands PerkinElmer's footprint in food testing.
- Perten's top line is ~$65M. It should contribute ~$0.04 to PKI's earnings in 2015.
- Privately-held Transposagen Biopharmaceuticals enters into a research collaboration and worldwide license agreement with J&J's (JNJ -0.9%) Janssen Biotech to develop allogeneic Chimeric Antigen Receptor T-cells (CAR-T).
- CAR-T therapies have shown promise in early clinical trials for the treatment of blood cancers. They have the potential to be used "off the shelf" without the need to match donor with recipient.
- Under the terms of the agreement, Janssen will pay Transposagen up to $292M which includes an undisclosed upfront fee and development-, regulatory- and commercial-related milestones. It will also pay tiered royalties on net sales of any allogeneic CAR-T products commercialized by Janssen.
- Transposagen will enter into a three-year research collaboration with Janssen focused on preclinical research. Janssen will be responsible for the manufacturing and commercialization of allogeneic CAR-T therapies.
- Holders of 22.8M warrants with an exercise price of $2 choose to exercise after Ekso Bionics Holdings (OTCQB:EKSO +3.3%) reduces the exercise price to $1, a 36% discount from its recently-traded price of $1.56.
- Proceeds will fund an expansion of its commercialization efforts of its robotic exoskeleton.
- The FDA designates privately-held Catabasis Pharmaceuticals' investigational NF-kB inhibitor, CAT-1004, an Orphan Drug for the treatment of Duchenne muscular dystrophy (DMD).
- NF-kB is a key mediator of cellular injury. Evidence suggests that activated NF-kB contributes to the underlying pathology of DMD.
- In a Phase 1 trial, CAT-1004 was well-tolerated and demonstrated a significant reduction of activated NF-kB. The company plans to proceed to Phase 2 development in 1H 2015.
- Among the benefits of Orphan Drug designation is a seven-year period of market exclusivity if approved.
- DMD-related tickers: (SRPT +7.6%)(RNA +63.3%)(BMRN +1.7%)(PTCT +3.4%)(OTCQB:MRNA -3.3%)(ROSG +0.8%)
- Amgen (AMGN +0.9%) terminates all company-sponsored clinical trials of rilotumumab in advanced gastric cancer. Its decision is based on a safety review by the independent data monitoring committee that found an increase in deaths in the rilotumumab and chemotherapy treatment arm compared to the chemo alone group. Protocol-defined futility criteria would have likely have been met at the planned interim analysis scheduled for March 2015.
- EVP of R&D Sean E. Harper, M.D., says, "While we are disappointed with these results, we will work with lead investigators to further analyze the data in order to help inform future research and therapies in this area. There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide."
- Institutional pharmacy Omnicare (OCR -3%) signs a new five-year agreement with McKesson (MCK +1.8%) covering the sourcing and distribution of branded, specialty and generic pharmaceuticals. The new contract, which builds on their ten-year partnership, adds generic drugs as part of McKesson's OneStop program.
- The FDA completes its review of Synthetic Biologics' (SYN +15.8%) IND for SYN-004, an oral beta-lactamase enzyme for the prevention of Clostridium difficile (C. difficile) infection. antibiotic-associated diarrhea and secondary infections with healthcare-acquired, drug-resistant pathogens in patients receiving IV beta-lactam antibiotic therapy. The company may now proceed to the clinical trial stage.
- It intends to start Phase 1a and 1b trials shortly. Top-line data are expected before the end of 2014.
- SYN-004 is a prophylactic treatment designed to prevent the development of C. diff infection. It acts by binding with and neutralizing certain common IV beta-lactam antibiotics in the gut thereby blocking the unintended harmful effects of antibiotics in the gastrointestinal tract by maintaining the natural balance of bacterial flora.
- Australia's Therapeutic Goods Administration approves Ariad Pharmaceuticals' (ARIA +8%) Iclusig (ponatinib) for the treatment of chronic myeloid leukemia in patients whose disease is resistant to or who are intolerant of at least two prior tyrosine kinase inhibitors, or if the patient has a T315I mutation and for the treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia in patients resistant to or intolerant of dasatinib and for whom subsequent treatment with imatinib in not clinically appropriate or where there is a T315I mutation.
- Ariad plans to launch Iclusig in Australia in early 2015.
- Endo International (ENDP +2.1%) secures the exclusive rights to Trimel BioPharma's Natesto (testosterone nasal gel) for the U.S. and Mexico. Under the terms of the agreement, Endo will pay Trimel $25M upfront plus additional regulatory- and sales-based milestones. Trimel will be responsible to manufacturing and supply and Endo will pay a tiered price based on volume.
- Natesto is an androgen indicated for replacement therapy in males with hypogonadism. It the first and only nasal gel for this indication. The FDA approved it in May 2014.
- Merck (MRK -0.5%) submits a new drug application to the Japanese Pharmaceuticals and Medicinal Devices Agency for omarigliptin for the treatment of type 2 diabetes. Japan is the first country with a regulatory filing for the drug candidate.
- Omarigliptin is a once-weekly DPP-4 inhibitor. Merck's Januvia (sitagliptin), approved by the FDA in 2006, was the first agent in the class to achieve regulatory clearance.
- Merck (MRK -0.7%) enters into an exclusive worldwide license agreement with NewLink Genetics (NLNK +0.5%) to develop and commercialize the latter's investigational rVSV-EBOV (Ebola) vaccine candidate.
- Phase 1 trials are currently underway at Walter Reed Army Institute of Research and the NIAID at the NIH. If successful, the NIH will commence a large, randomized Phase 3 study to evaluate the safety and efficacy of rVSV-EBOV and another investigational Ebola vaccine candidate co-developed by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK -0.3%).
- The rVSV-EBOV vaccine was created by scientists at the Public Health Agency of Canada's National Microbiology Laboratory.
- Bristol-Myers Squibb (NYSE:BMY) and Five Prime Therapeutics (NASDAQ:FPRX) enter into an exclusive clinical collaboration agreement to evaluate the immunotherapy combination of BMY's investigational PD-1 inhibitor Opdivo (nivolumab) and Five Prime's monoclonal antibody, FPA008, that inhibits colony stimulating factor-1 receptor (CSF1R) as a potential treatment for various cancers.
- The initial Phase 1a/1b study will assess the combination in non-small cell lung cancer, melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.
- Opdivo is currently approved in Japan for the treatment of patients with unresectable melanoma.
- Under the terms of the agreement, BMY will make a one-time payment of $30M to FPRX and will be responsible to study costs. FPRX will conduct the clinical trial, which should commence in 2015.The contract provides for exclusivity with respect to the development, with a collaboration partner, of combination regimens of anti-PD-1/PDL1 antagonists together with an anti-CSF1R antagonist. BMY has a time-limited right of first refusal subject to certain conditions if FPRX wishes to seek a partner for FPA008.
- Previously: Bristo-Myers plans a Q3 BLA submission for Opdivo
- Previously: EMA accepts Opdivo MAA
- Previously: Bristol-Myers' Opdivo delivers in Phase 2 NSCLC trial
- Sarepta Therapeutics (NASDAQ:SRPT) is up 14% premarket on robust volume in response to BioMarin Pharmaceuticals' (NASDAQ:BMRN) announced acquisition of Prosensa Holding N.V. (NASDAQ:RNA) for $680M.
- Some observers believe Sarepta's Duchenne muscular dystrophy drug eteplirsen is better than Prosensa's drisapersen which makes it a more attractive acquisition target.
- Previously: BioMarin buys Prosensa
- Previously: Sarepta +11.2% following FDA statement
- Tetraphase Pharmaceuticals (NASDAQ:TTPH) is reportedly considering selling itself after being approached by interested suitors. Sources say the acquirer could be Acetelion (OTCPK:ALIOF) (OTC:ALIOY) or Roche (OTCQX:RHHBY).
- The attraction is Tetraphase's antibiotic eravacycline, currently in Phase 3 development. Both oral and IV formulations of the drug have demonstrated higher dose response rates than Johnson & Johnson's (NYSE:JNJ) Levaquin (levofloxacin) for the treatment of complicated urinary tract infections. In the Ignite-2 study, patients receiving 200 mg eravacycline IV-to-oral doses achieved a response rate of 70.8% while patients receiving 250 mg IV-to-oral doses achieved 64.3%, both significantly ahead of Levaquin's 52.2% response rate.
- A trial comparing eravacycline to Merck's (NYSE:MRK) Invanz (ertapenem) for the treatment of complicated intra-abdominal infections is underway.
- TTPH is up 18% premarket on light volume.
- Previously: Tetraphase completes eravacycline Phase 3 enrollment
- The European Commission approves Novartis' (NYSE:NVS) Signifor (pasireotide) for the treatment of adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadaquately controlled on treatment with a first-generation somatostatin analogue (SSA).
- The once monthly injection directly targets the pituitary tumor and gives patients an alternative treatment option for those who are inadaquately controlled by SSAs.
- Signifor is currently approved in over 60 countries for the treatment of Cushing's disease.
- Enanta Pharmaceuticals (ENTA -1.1%) FQ4 results: Revenues: $2.6M (+100.0%); Operating Expenses: $8M (+31.1%); Operating Loss: ($5.3M) (-12.8%); Net Loss: ($5M) (-13.6%); Loss Per Share: ($0.27) (-8.0%).
- FY2014 results: Revenues: $47.7M (+48.6%); Operating Expenses: $28.8M (+25.2%); Operating Income: $19M (+111.1%); Net Income: $34.4M (+621.2%); EPS: $1.80 (+368.7%); Quick Assets: $90.8M (-10.5%).
- No guidance given.