Tue, Mar. 24, 5:34 PM
- A Phase 2a clinical trial evaluating Lpath's (NASDAQ:LPTN) candidate for advanced renal cell carcinoma (RCC), ASONEP, failed to achieve its primary efficacy endpoint of a statistically significant improvement in progression-free survival (PFS). The study enrolled RCC patients who had previously failed treatment with at least one anti-vascular endothelial factor (VEGF) agent and no more than one mTOR inhibitor. This patient population is considered "last line."
- To meet the endpoint, 25 of 39 patients needed to be progression-free at Month 2 of treatment, but the overall median time to progression was less than that. Seven patients were progression-free at least six months and three were progression-free for more than 29 months.
- ASONEP is an anti-S1P antibody formulated for systemic use. S1P is sphingosine-1-phosphate, a blood-borne lipid mediator that is a key regulator of vascular and immune systems. It is upregulated (there is more of it) in certain cancers so binding to it may potentially inhibit progression.
- The company will assess its options with a partner to explore areas that present the greatest chance of success for ASONEP. Another Phase 2 study is evaluating the ocular version, iSONEP, in wet age-related macular degeneration. Data readout should happen in Q2. Pfizer (NYSE:PFE) has an exclusive option for a global license. Pfizer has a time-limited right of first refusal for a license for ASONEP.
- LPTN is down 27% after hours on robust volume.
Thu, Feb. 12, 12:56 PM
- Johnson & Johnson (JNJ -1.6%) slumps on double normal volume after U.S. Patent Office upholds the rejection of its Remicade 2018 patent. Biosimilar makers rally as a result, including thinly-traded nano cap Epirus Biopharmaceuticals (EPRS +15.1%) whose lead product is BOW015, a biosimilar version of Remicade (infliximab).
- Biosimilar-related tickers: (PFE +1.3%)(HSP +0.1%)(AMGN -0.4%)(CHRS +0.2%)(PFNX +14.5%)(NVS -0.2%)
Thu, Feb. 5, 3:51 PM
- Pfizer's (PFE +3%) acquisition of biosimilar developer Hospira (HSP +35.2%) has speculators moving into several smaller players.
- Thinly-traded Coherus BioSciences (CHRS +13.2%) is up on a 3x surge in volume albeit on turnover of only 600K. Its lead product is a biosimilar version of Amgen's Enbrel (etanercept).
- Thinly-traded Epirus Biopharmaceuticals (EPRS +3.3%) is up also on 3x higher volume but, again, on light turnover of 276K shares. Its lead product is a biosimilar version of Janssen's Remicade (infliximab).
- Previously: Coherus Bio stumbles in debut (Nov. 6, 2014)
- Previously: Sandoz success powers Epirus Bio (Jan. 8)
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Dec. 15, 2014, 8:56 AM
- Opko Health (NYSE:OPK) is up 14% premarket on robust volume in response to its deal with Pfizer (NYSE:PFE). The latter will be pay Opko an upfront fee of $295M and up to $275M in regulatory milestones for the global rights to hGH-CTP, a long-acting growth hormone. Its value proposition is a once-weekly injection, a significant improvement over the once-daily standard of care.
- Opko acquired the rights to hGH-CTP via its takeout of Israel-based Prolor last year.
- Previously: Opko completes its acquisition of Prolor Biotech (Aug. 29, 2013)
Oct. 27, 2014, 9:26 AM
- Durect Corp. (NASDAQ:DRRX) and Pain Therapeutics (NASDAQ:PTIE) drop 46% and 54%, respectively, on robust volume after Pfizer (NYSE:PFE) decides to discontinue its agreement to development and commercialize Romoxy (oxycodone).
- Pfizer will return all rights, including the responsibility for regulatory activities to Pain, who licensed the product from Durect.
Oct. 1, 2014, 12:10 PM
- Thinly-traded Portola Pharmaceuticals (PTLA +15.5%) jumps on a 2x surge in volume albeit on turnover of less than 600K shares in response to its announcement of positive results from a Phase 3 clinical trial evaluating the safety and efficacy of andexanet alfa as an antidote to a Factor Xa inhibitor.
- Top-line efficacy data demonstrated that an IV bolus of andexanet alfa immediately and significantly reduced the anticoagulation activity of Bristol-Myers Squibb (BMY -1.4%) and Pfizer's (PFE -1.3%) direct Factor Xa inhibitor Eliquis (apixaban). The results were highly statistically significant.
- CEO William Lis says, "Andexanet alfa represents a potential important advance to the field of anticoagulation for Factor Xa inhibitor patients who suffer a major bleeding episode or those requiring emergency surgery."
- The company expects to file a BLA with the FDA for the Breakthrough Therapy-designated product candidate by the end of 2015.
Sep. 26, 2014, 11:46 AM
- Shares of thinly-traded nano cap GlycoMimetics (GLYC -5.5%) are under pressure in response to Pfizer's (PFE -1.2%) notification that it will significantly delay the start of its Phase 3 clinical trial of GMI-1070 (rivipansel) due to a manufacturing development issue impacting formulated drug supply. Pfizer says that it will advise GLYC on a more specific timeframe regarding the commencement of the trial after it identifies the cause of the problem and a remedy.
- GLYC expected the trial to start in Q4. Its exclusive license agreement with Pfizer was signed in October 2011. The initial indication will be a treatment for vaso-occlusive crisis of sickle cell disease.
Sep. 23, 2014, 2:27 PM
- Pfizer (PFE -0.6%) approached Actavis (ACT +3.3%) to "express its interest in an acquisition," sources tell Bloomberg. However, the news service adds the companies "aren’t currently in formal talks and Pfizer hasn’t made an offer."
- Actavis has spiked on the report. Pfizer, interested in doing a tax inversion deal, made a rejected bid to acquire AstraZeneca earlier this year. Actavis was reported yesterday to have made a rejected offer for Allergan (AGN +1.4%), which is reportedly in advanced talks to buy Salix.
- Yesterday, the Treasury Department announced it's close to finalizing rules meant to discourage U.S. companies from doing inversion deals.
Jul. 8, 2014, 3:59 PM
- Shares of Zogenix (ZGNX -12.9%) tumble today on more than a 2x surge in volume in response to the competitive threat from Purdue. The FDA granted its tamper-resistant hydrocodone product Priority Review which means that it could debut in the U.S. by the end of 2014.
- Zogenix is working on its own abuse deterrent version of Zohydro. It plans to submit an sNDA in October. The time frame for regulatory review may delay its U.S. launch until the mid-2015, however.
- Related tickers: (ABBV -3%) (TEVA -1.7%) (ALKS -2.4%) (MNK -2.2%) (PFE -1.1%)
May. 19, 2014, 3:27 AM
- As tipped, AstraZeneca (AZN) has rejected Pfizer's (PFE) final proposal of £55 a share, or £69B ($117B), saying that the bid "falls short of AstraZeneca’s value as an independent science-led company."
- AstraZeneca told Pfizer on Friday that any offer would have to be over 10% above the latter's previous bid of £53.50.
- The U.K. company said that while Pfizer's pursuit has been driven by cost and tax savings, it "has failed to make a compelling strategic, business or value case."
- Pfizer's final proposal "would present significant risks for shareholders, while also having serious consequences for the company, our employees and the life-sciences sector in the U.K., Sweden and the U.S.," AstraZeneca said.
- AstraZeneca's shares are -13.2% at £41.87 in London. (PR)
May. 18, 2014, 9:13 PM
- "They can either accept or reject it," says Pfizer (PFE) CEO Ian Read of his company's "final" offer for AstraZeneca (AZN) valued at about $120B. "They have until the 26th of May," under U.K. takeover rules.
- The new offer increases the cash component of the deal to 45% of the total price, values AstraZeneca shares at £55 ($92.48) each, and comes after some back and forth between the companies that started on Thursday with Pfizer offering £53.50. AstraZeneca, according to Read, said £53.50 substantially undervalues the company. "If that is what you believe, I really cannot find a way to close a substantial gap," Read says he told AZN at the close of a Sunday phone call.
Apr. 28, 2014, 7:37 AM
- AstraZeneca's (AZN) BOD responds to Pfizer's press release about its offer to buy the former for $76.62/share.
- According to AZN, Pfizer (PFE) chief Ian Read first contacted Chairman Leif Johansson on November 25, 2103 about a potential combination. Mr. Johansson expressed confidence in his firm's prospects but agreed to meet his counterpart in New York on January 5, 2014. At this meeting Pfizer made a preliminary offer for AZN of £13.98 in cash plus 1.758 shares of PFE stock representing a value of £46.61 ($76.61) per AZN share based on PFE's closing price of $30.52 on January 3. PFE's proposal also included a new U.S. listed and headquartered holding company.
- AZN's BOD felt that the proposal significantly undervalued AZN and its prospects. It was also concerned that 70% of the deal was PFE stock. Still another problem was the intended inversion structure where PFE would redomicile to the U.K. for tax purposes.
- On January 12 AZN wrote to PFE rejecting its offer. PFE responded on January 15 that it was no longer actively considering an offer for AZN.
- The AZN BOD reaffirms its commitment to its strategy announced in March 2013.
- In the meantime, PFE contacted the U.K. government about the merits of the deal.
- On April 26 Mr. Read contacted Mr. Johansson requesting they make a joint statement stating they were entering discussions about a combination despite the absence of a new offer. The AZN BOD declined to do so without first seeing a new proposal.
- Pfizer has scheduled an investor conference call this morning at 8:30 am EDT to discuss the matter.
- AZN shares are up 16% premarket on robust volume.
Mar. 12, 2014, 2:23 PM
Feb. 4, 2014, 10:28 AM
- Pfizer (PFE +2.7%) leads the Dow out of the gate after Jefferies upgrades shares to Buy from Hold and raises its target price to $38 from $33.
- The upgrade comes a day after PFE announced positive results from its palbociclib experimental breast cancer treatment, which the firm believes could be approved as soon as the end of this year.
- The firm also likes PFE's reorganization of its commercial operations, which might make its business more efficient and improve its tax structure; the creation of the division focused on products that are losing protection also may prompt future acquisitions or joint ventures.
PFE vs. ETF Alternatives
Pfizer Inc is a research-based biopharmaceutical company. The Company has five operating segments: Primary Care; Specialty Care and Oncology; Established Products and Emerging Markets; Animal Health; and Consumer Healthcare.
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