Will AstraZeneca Get Bought After All?
Chris DeMuth Jr. • 20 Comments
Chris DeMuth Jr. • 20 Comments
The Preferred Way To Play The Allergan-Pfizer Break Up
Andrew Walker, CFA • 56 Comments
Andrew Walker, CFA • 56 Comments
Yesterday, 10:25 AM
- Intrepid biotech investors are, no doubt, seriously considering deploying some cash today in response to the (hopefully temporary) bearish reaction to the Brexit vote. Nasdaq is currently down 2.7%, the Dow 2.2% and the IBB 3.3%.
- Representative tickers: (GILD -2.2%)(GSK -2.4%)(AZN -2.7%)(PFE -1.1%)(MRK -1.9%)(CELG -3.2%)(BMY -2%)(BIIB -2.4%)(AMGN -2.7%)(AGN -2.8%)(TEVA -0.8%)(ABT -3.4%)(MDT -1.4%)
Wed, Jun. 22, 7:21 AM
- Thinly traded nano cap Pluristem Therapeutics (NASDAQ:PSTI) is up 11% premarket on light volume in response to its announcement of preclinical data that suggest its PLX-PAD cells may be effective in treating Duchenne muscular dystrophy.
- In a mouse model study, PLX-PAD cells reduced an enzyme called creatine phosphokinase (CPK), a marker of muscle degeneration or injury, by ~50% compared to placebo. In addition, analyses of tissue samples showed reduced levels of inflammation and necrosis (death of most of the cells in an organ or tissue) and evidence of regeneration of muscle tissue.
- PLX cells are mesenchymal-like adherent stromal cells derived from full term human placentas that may be administered without the need for HLA matching. According to the company, PLX-PAD (peripheral artery disease) cells have demonstrated the ability to stimulate the growth of new blood vessels in preclinical models inducing muscle tissue regeneration and improving muscle function.
- PLX-PAD is currently under development for the treatment of critical limb ischemia, intermittent claudication (leg cramps caused by the obstruction of arteries), muscle injury, pulmonary arterial hypertension and preeclampsia.
- DMD-related tickers: (NASDAQ:SRPT)(NASDAQ:BMRN)(NASDAQ:SMMT)(NASDAQ:PTCT)(NYSE:PFE)(OTCQB:MRNA)
Thu, Jun. 16, 4:48 PM
- A Phase 3 clinical trial, OASIS, evaluating Paratek Pharmaceuticals' (NASDAQ:PRTK) omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) met all efficacy endpoints.
- The 645-subject study assessed IV-to-oral once-daily omadacycline compared to twice daily linezolid [Pfizer's (NYSE:PFE) ZYVOX] over a 7-14-day course of therapy.
- The primary endpoint for the FDA was Early Clinical Response (ECR) at 48-72 hours after the first dose in the modified Intent-to-Treat population (mITT) (patients without an infection that could be caused by a single species of Gram-negative bacteria). In this group, omadacycline was shown to be non-inferior (no worse than) to linezolid. The ECR for each medication was 84.8% and 85.5%, respectively.
- The co-primary endpoints for the European Medicines Agency were an assessment of clinical response at the post-treatment evaluation (PTE) in the mITT and clinically evaluable (CE) populations. In both groups, omadacycline again demonstrated non-inferiority to linezolid. In the mITT population at PTE, the clinical success rates for omadacycline and linezolid were 86.1% and 83.6%, respectively. In the CE population at PTE, the clinical success rates were 96.3% and 93.5%, respectively. Omadacycline showed comparable clinical success rates to linezolid across the most common ABSSSI pathogens, including methicillin-resistant Staphylococcus aureus (MRSA).
- Treatment-emergent adverse events were similar between the two groups. The most common were gastrointestinal events (18.0% for omadacycline vs. 15.8% for linezolid), including nausea (12.4% vs. 9.9%) and vomiting (5.3% vs. 5.0%).
- Omadacycline, a tetracycline antibiotic known as an aminomethylcycline, has broad spectrum activity against Gram-positive, Gram-negative and atypical bacteria.
- OASIS is the first of two pivotal studies that will support regulatory applications in the U.S. and Europe.
- Complete results will be presented at an upcoming scientific conference.
- Shares are up 18% after hours on robust volume.
Mon, May 23, 10:12 AM
- Exelixis (EXEL +6.7%) moves up on average volume in response to its announcement of positive results from a Phase 2 study, called CABOSUN, assessing lead cancer candidate cabozantinib for the first-line treatment of patients with advanced intermediate- or poor-risk renal cell carcinoma (RCC). The study met its primary endpoint of a statistically significant improvement in progression-free survival (PFS) compared to sunitinib malate [Pfizer's (NYSE:PFE) SUTENT].
- CABOSUN is an open-label, active-controlled study that randomized 150 advanced RCC patients 1:1 to receive cabozantinib (60 mg once daily) or sunitinib (50 mg once daily, four weeks on, two weeks off).
- The company intends to meet with regulators to discuss the development and submission strategy for the first-line indication. The FDA approved cabozantinib, branded as CABOMETYX, last month for the treatment of RCC patients who have received prior angiogenic therapy.
- Final results will be presented at a future medical conference.
- Previously: FDA approves Exelixis' lead cancer drug cabozantinib; shares up 9% premarket (April 26)
Mon, May 16, 7:14 AM
- Pfizer (NYSE:PFE) agrees to acquire Palo Alto, CA-based Anacor Pharmaceuticals (NASDAQ:ANAC) for $99.25 per share or $5.2B net of cash. The deal should close in Q3.
- Anacor is the exclusive U.S. distributor of Sandoz's PharmaDerm's Kerydin (tavaborole) topical solution 5%, the first oxaborole antifungal indicated for the treatment of onychomycosis (toenail fungal infection). Its lead product candidate is crisaborole topical ointment 2% for the treatment of atopic dermatitis. Its New Drug Application (NDA) is currently under FDA review. The PDUFA date is January 7, 2017. Pfizer believes peak sales could reach $2B.
- Pfizer will finance the transaction with cash on hand. The deal will not impact its current 2016 guidance. The acquisition should be slightly dilutive to non-GAAP EPS in 2017 and accretive to non-GAAP EPS in 2018 and thereafter.
- ANAC is up 53% premarket on increased volume.
- Previously: FDA accepts Anacor's NDA for topical dermatitis treatment, action date January 7 (March 22)
- Previously: Anacor Pharma's Crisaborole successful in two late-stage studies; shares up 38% premarket (July 13, 2015)
Thu, May 12, 11:48 AM
- Kitov Pharmaceuticals (KTOV +10%) remains on track to file a New Drug Application (NDA) with the FDA seeking approval of lead product candidate KIT-302 by year end. The company's confidence in the timeline stems from the written minutes from its pre-NDA meeting with the agency.
- The FDA's feedback confirmed that six-month stability data will be acceptable and that an Advisory Committee review will not be required. Kitov also does not see a problem submitting the additional information requested, including market data, medical literature review of amlodipine and celecoxib in animals and the calculation of the primary efficacy endpoint using an alternative math technique, which KIT-302 met.
- Kitov intends to submit its marketing application under the abbreviated 505(b)(2) pathway which, if accepted, will enable approval in 2017.
- KIT-302 is a combination drug that treats osteoporosis-related pain (celecoxib, branded as Celebrex by Pfizer (PFE -0.3%)) and hypertension (amlodipine besylate, branded as Norvasc).
Thu, May 5, 9:14 AM
- In a letter to Medivation's (NASDAQ:MDVN) board, Sanofi (NYSE:SNY) CEO Olivier Brandicourt reiterates his firm's strong desire to negotiate the terms of an acquisition, saying its $9.3B offer ($52.50 per share) represents a tidy 50% premium over what shares were trading three months before.
- He also says Sanofi has had extensive discussions with Medivation's top shareholders and they back the deal. Going a step further, he says Sanofi is prepared to go directly to shareholders if management does not proceed.
- A competing bid appears likely [Pfizer (NYSE:PFE), AstraZeneca (NYSE:AZN)] so whatever Medivation decides to do, Sanofi will probably have to up its offer.
- MDVN is up a fraction premarket while SNY is down 3%.
- Update: Medivation reiterates that Sanofi's bid is "substantially inadequate."
Tue, May 3, 6:34 PM
- Medivation (NASDAQ:MDVN) +3.9% AH following a Reuters report that Pfizer (NYSE:PFE) has approached the company to express interest in an acquisition, raising the possibility of a bid rivaling Sanofi's (NYSE:SNY) $9.3B offer by Sanofi.
- MDVN has not yet decided whether it should engage with PFE in negotiations and is in discussions with its financial and legal advisers, according to the report.
- MDVN last week rejected SNY's $52.50/share takeover proposal, and PFE, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have been speculated as potential suitors.
Tue, May 3, 7:43 AM
- Pfizer (NYSE:PFE) Q1 results ($M): Total Revenues: 13,005 (+19.7%); GEP: 4,773 (-4.8%); GIP: 3,640 (+18.4%): Vaccines: 1,570 (+18.2%); Consumer Healthcare: 822 (+1.7%); Oncology: 1,001 (+89.6%); Hospira: 1,199. Consensus: $12.02B.
- Net Income: 3,016 (+26.9%); Non-GAAP Net Income: 4,155 (+30.0%); EPS: 0.49 (+28.9%); Non-GAAP EPS: 0.67 (+31.4%). Consensus: $0.55.
- Key Product Sales: Prevnar Family: 1,509 (+15.5%); Lyrica: 1,229 (+3.5%); Enbrel (ex. U.S. & Canada): 733 (-3.4%); Ibrance: 429 (+999%); Lipitor: 411 (-6.8%); Viagra: 396 (0.0%); Sutent: 278 (+14.9%); Premarin Family: 256 (+10.3%); Norvasc: 236 (-6.3%); Cantix/Champix: 220 (+39.2%); Celebrex: 172 (-16.1%).
- 2016 Guidance: Revenues: $51B - 53B; EPS: $1.72 - 1.85; Non-GAAP EPS: $2.38 - 2.48.
- Q2 Consensus: EPS of $0.59 on revenues of $12.79B.
- Shares are up 2% premarket on increased volume.
Tue, May 3, 6:46 AM
Fri, Apr. 29, 3:09 PM
- Also mentioned alongside AZN and PFE as weighing bids for Medivation (MDVN +2.3%) is Novartis (NYSE:NVS), according to the report.
- Earlier today, Medivation rejected Sanofi's (SNY -4.6%) $9.3B, or $52.50 per share offer, with one of Bloomberg's sources saying the company is looking for at least $65 per share. Sanofi has the capacity to go higher, say sources, but is naturally reluctant to overpay.
Fri, Apr. 15, 9:24 AM
- ARIAD Pharmaceuticals (NASDAQ:ARIA) is up 10% premarket on robust volume in response to its announcement of updated data from its ongoing Phase 1/2 study assessing brigatinib for the treatment of patients with advanced malignancies, including a certain type of non-small cell lung cancer (NSCLC). The results were presented at the 6th European Lung Cancer Conference in Geneva, Switzerland.
- The data included safety and pharmacokinetic data on 137 patients and efficacy analyses on 79 patients with ALK+ NSCLC who were on treatment for a median time of 12.6 months. The primary efficacy endpoint is overall response rate. Secondary endpoints include safety, tolerability, pharmacokinetics, progression-free survival (PFS) and overall survival.
- The overall survival rate at one year was 100% in patients who had not been treated with Pfizer's (NYSE:PFE) Xalkori (crizotinib) and 81% in those who had been treated with crizotinib. In 70 evaluable ALK+ NSCLC patients previously treated with crizotinib, median PFS was 13.4 months (median PFS in the crizotinib-naive group has not been reached). Almost all of the evaluable ALK+ NSCLC patients showed tumor shrinkage, with 25 (35.7%) experiencing 100% shrinkage of the target lesion.
- The most common treatment-emergent adverse events were nausea (52%), fatigue (42%), diarrhea (40%), headache (33%) and cough (32%).
- Phase 3-stage brigatinib is an oral inhibitor of an enzyme called anaplastic lymphoma kinase (ALK). The abnormal expression of ALK is a key driver of certain types of non-small cell lung cancer, neuroblastomas and anaplastic large cell lymphoma. It is not generally expressed in normal adult tissues so it is a promising therapeutic target.
Mon, Apr. 11, 8:24 AM
- Can-Fite BioPharma (NYSEMKT:CANF) announces that its candidate for the treatment of erectile dysfunction (ED), CF602, showed statistically significant full recovery one hour after a single 500 u/kg dose in a preclinical diabetic rat model.
- According to the company, CF602's novel mechanism of action may provide a treatment benefit to patients who do not respond adequately to PDE5 inhibitors [Pfizer's (NYSE:PFE) Viagra (sildenafil citrate), Eli Lilly's (NYSE:LLY) Cialis (tadalafil), Bayer (OTCPK:BAYRY) and GlaxoSmithKline's (NYSE:GSK) Levitra (vardenafil HCl)].
- Last October, the company announced the results from a preclinical study that showed CF602 restored the impaired vascular endothelial growth factor system in the penises of diabetic rats which induced an increase in nitric oxide which resulted in improved penile erection compared to placebo. Its unique mechanism of action is apparently similar to Viagra.
- The company intends to file an Investigational New Drug (IND) with the FDA in Q4.
- Shares are up 7% premarket on increased volume.
- Previously: Can-Fite's CF602 shows Viagra-like action in diabetic rats; shares up 10% premarket (Oct. 22, 2015)
Wed, Apr. 6, 7:26 AM
- Although disheartened that its merger with Pfizer (NYSE:PFE) is dead, Allergan (NYSE:AGN) is bullish on its standalone profile. CEO Brent Saunders says, "While we are disappointed that the Pfizer transaction will no longer mover forward, Allergan is poised to deliver strong, sustainable growth built of a set of powerful attributes. Our pipeline is one of the strongest in the industry, loaded with 70 mid-to-late-stage programs including 14 expected approvals and 16 regulatory submissions in 2016 alone."
- Based on a preliminary review of the proposed regulations from the U.S. Treasury Department, the company believes they will not have a material impact on its standalone tax rate. Q1 earnings will be reported no later than May 10. During the conference call, management will update investors on its plans to simplify the company's operations after it divests its generics business to (NYSE:TEVA).
- Allergan will host a brief conference call this morning at 10:00 am ET to discuss its standalone prospects.
- Pfizer says it will make a decision on splitting the company's innovative and established businesses by the end of the year. It will report Q1 results on May 3. It has agreed to reimburse Allergan $150M for merger-related expenses.
- PFE is up 1% and AGN is down 1% premarket.
Tue, Apr. 5, 9:17 PM
- Pfizer (PFE +2.2%) and Allergan (AGN -15%) are set to mutually terminate their merger in the morning, David Faber reports in news that's not entirely unexpected.
- The change to tax inversion regulations gave the deal a "death blow," he says.
- Updated 9:46 p.m.: Pfizer will pay Allergan a $400M breakup fee in keeping with the companies' agreement.
- Previously: Pfizer mulling backing out of Allergan deal (Apr. 05 2016)
- Previously: Allergan -19% following Secretary Lew’s remarks on corporate tax inversions (Apr. 05 2016)
- Now read Pfizer Is A Winner With Or Without Allergan »
Tue, Apr. 5, 1:46 PM
- According to sources, Reuters reports that Pfizer (PFE +3.2%) is leaning toward abandoning the Allergan (AGN -16.4%) deal if the tax benefits are not there.
- Previously: Allergan -19% following Secretary Lew’s remarks on corporate tax inversions (April 5)
Pfizer, Inc. is a research-based, global biopharmaceutical company, which engages in the manufacture of vaccines and injectable biologic medicines. It operates through the following segments: Global Innovative Pharmaceutical, Global Vaccines, Oncology and Consumer Healthcare, and Global... More
Industry: Drug Manufacturers - Major
Country: United States
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