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Tue, Jun. 7, 5:16 AM
- U.S. District Judge Beth Labson Freeman has found a pattern of misconduct by Merck & Co (NYSE:MRK) including lying under oath and other unethical practices, freeing Gilead Sciences (NASDAQ:GILD) from paying damages for infringing on Merck's patents with its hepatitis C treatments - Sovaldi and Harvoni.
- The ruling comes after a federal jury on March 24 ordered Gilead to pay $200M in damages, based on findings that Merck's patents were valid.
- GILD +0.4% premarket
Sun, Jun. 5, 8:44 AM
- Merck (NYSE:MRK) today announced findings from three separate studies evaluating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in combination with other treatment regimens including talimogene laherparepvec, dabrafenib plus trametinib, or low-dose ipilimumab in patients with advanced melanoma.
- These data, from MASTERKEY-265, KEYNOTE-022, and KEYNOTE-029, respectively, are included in the 52nd Annual Meeting of the American Society of Clinical Oncology ("ASCO") in Chicago (Abstracts #9568, #3014, and #9506).
- “We continue to build on our leadership in advanced melanoma by evaluating KEYTRUDA with multiple combination partners utilizing diverse mechanisms of action with the goal of improving outcomes while maintaining tolerability,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “These encouraging early data point to the potential for KEYTRUDA to become an important component of combination therapy in melanoma.”
- Key findings can be found in the press release.
Tue, May 31, 10:05 AM
- Interim data from four patients with Homozygous Familial Hypercholesterolemia (HoFH) treated with Regeneron Pharmaceuticals' (REGN +0.4%) evinacumab (REGN1500) experienced significant reductions in low-density lipoprotein cholesterol (LDL-C) levels. The results were presented at the 84th European Atherosclerosis Society Congress in Innsbruck, Austria.
- The patients achieved a mean reduction of 55% of LDL-C versus baseline (range: 25 - 90%) after a single 250 mg subcutaneous injection at baseline followed by a 15mg/kg IV infusion at week 2. All patients were receiving maximum doses of statin plus ezetimibe [Merck's (MRK) Zetia]. Evinacumab was generally well-tolerated with no adverse events leading to discontinuation. The most common drug-related adverse events were injection site reactions.
- The ongoing single-arm, open-label study will enroll up to eight HoFH patients.
- HoFH is the most severe form of hypercholesterolemia. It's rare, affecting less than 1,000 Americans, but sufferers have levels of "bad cholesterol" up to 1,000 mg/dL, ten times the optimal amount.
- Evinacumab, created with the company's VelocImmune technology platform, is a human monoclonal antibody that binds to a protein called angiopoietin-like 3 (ANGPTL3), a natural inhibitor of an enzyme that plays a key role in the breakdown of triglycerides and other lipids.
Fri, May 27, 8:17 AM
- The European Medicine's Agency's Committee for Medicinal Products for Human Use (CHMP) adopts a positive opinion recommending approval of Merck's (NYSE:MRK) ZEPATIER (elbasvir/grazoprevir) for the treatment of hepatitis C virus (HCV) infection in adults (genotypes are not specified).
- ZEPATIER is a once-daily, fixed-dose combination of an NS5A inhibitor (elbasvir) and an NS3/4A protease inhibitor (grazoprevir). In January 2016, the FDA approved it for the treatment HCV genotypes 1 and 4, with or without ribavirin.
- A final decision from the European Commission usually takes ~60 days.
Tue, May 24, 2:42 PM
Mon, May 23, 4:52 PM
- The FDA accepts for review the Biologics License Application (BLA) from Samsung Bioepis for SB2, its biosimilar to Janssen's (NYSE:JNJ) Remicade (infliximab). SB2 is the company's first biosimilar to be submitted for review in the U.S.
- If approved, Merck (NYSE:MRK) will be responsible for marketing and distribution.
- Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen (NASDAQ:BIIB). It has 13 biosimilar candidates in its pipeline, including six in its first wave.
Tue, May 17, 3:02 AM
- The U.S. Supreme Court has backed out of a divisive clash involving religious groups that object to mandatory contraceptive coverage under Obamacare, issuing a compromise that said the two sides might be able to work out their differences.
- With four conservative justices and four liberals, the judges sent the case back to the lower courts, but suggested the government arrange coverage directly with health insurers rather than requiring employers to sign off on it.
- Related tickers: PFE, MRK, JNJ, TEVA, CHD, OTCPK:BAYRY
Wed, May 11, 4:51 AM
- The U.S. Attorney's Office for the Southern District of New York is investigating contracts between drugmakers and pharmacy benefit managers.
- Federal prosecutors have approached at least three companies, including Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK) and Endo International (NASDAQ:ENDP).
- When drugs are knocked off their formularies, patients may have to pay full price for them. PBMs often keep or dump a product depending on whether they can obtain favorable pricing.
Thu, May 5, 7:11 AM
- Merck (NYSE:MRK) Q1 Results ($M): Total Revenues: 9,312 (-1.2%); Pharmaceutical: 8,104 (-2.0%); Animal Health: 829 (0.0%).
- Net Income: 1,125 (+18.0%); Non-GAAP Net Income: 2,492 (+2.7%); EPS: 0.40 (+21.2%); Non-GAAP EPS: 0.89 (+4.7%). Q1 Consensus: EPS of $0.85 on revenues of $9.46B.
- Key Product Sales: Januvia: 906 (+2.5%); Zetia: 612 (+7.7%); Janumet: 506 (-0.6%); Gardasil: 378 (+5.3%); Proquad, MMRII & Varivax: 357 (+2.6%); Remicade: 349 (-30.3%); Isentress: 340 (-11.7%); Cubicin: 292 (+56.1%); Vytorin: 277 (-13.4%); Keytruda: 249 (+200.0%); Singulair: 237 (-3.3%); Nasonex: 229 (-20.8%).
- 2016 Guidance: Revenues: $39.0B - 40.2B from $38.7B - 40.2B; EPS: $1.96 - 2.23 (unch); Non-GAAP EPS: $3.65 - 3.77 from $3.60 - 3.75.
- Q2 Consensus: EPS of $0.91 on revenues of $9.80B.
Thu, May 5, 6:48 AM
Wed, May 4, 5:30 PM
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Mon, May 2, 1:22 PM
- A misstep by a Merck scientist prompts the judge to reopen the patent dispute between Merck (MRK +0.1%) and Gilead Sciences (GILD -0.4%). During the first trial, in which Merck was awarded $200M, the jury found that Gilead infringed on two Merck patents covering hep C med sofosbuvir, the active ingredient in Sovaldi and one of the active ingredients in Harvoni.
- A key witness was retired Merck scientist Phil Durette, who testified that he made early scientific advancements that led to sofosbuvir. Merck, however, considered buying Pharmasset which Gilead eventually acquired in November 2011 for $11B. During its diligence, Merck representatives conducted a conference call with Pharmasset, a call Durette was on, but told jurors that he was not. Unsurprisingly, Merck denies that jurors were deliberately misled and maintains that his testimony did not equate to the conduct of the company. Judge Labson Freeman believes the matter should be sorted out in court.
- Merck originally wanted a 10% royalty on the ~$21B Gilead generated from sales of the two drugs. The jury settled on a 4% royalty on $5B in sales, deducting Gilead's overall investment of $15B.
- Previously: Gilead Sciences ordered to pay $200M to Merck in patent case (March 24)
- Update: Mr. Durette appears to be a patent attorney, not a retired scientist. Gilead asserts that he misrepresented his position on the telephone call with Pharmasset and violated confidentiality provisions when he prosecuted one of the patents after he realized Pharmasset was close to developing sofosbuvir.
Mon, May 2, 10:34 AM
- According to comments from competitors AbbVie (ABBV +0.6%) and Gilead Sciences (GILD -0.4%), Merck (MRK +0.2%) is grabbing share in the hepatitis C virus (HCV) market with aggressive pricing of combo treatment Zepatier (elbasvir and grazoprevir), approved by the FDA in January.
- AbbVie appears to have taken the biggest hit. CEO Rick Gonzalez commented in last week's Q1 earnings call that Merck "has been more aggressive than we anticipated from a pricing standpoint" which contributed to V-Pak coming up $111M short of expectations (Q1 sales: $414M). In the U.S., sales were $125M, $70M shy of views.
- Gilead also missed views for top-seller Harvoni, falling $200M short of the consensus of $3.26B. The U.S. was the toughest market, with sales of $1.41B, well shy of the $1.88B analysts expected.
- Zepatier's list price is $54,600 per regimen, well below V-Pak's $83,319 and Harvoni's $94,500. Merck, though, has been offering significant discounts off list to which AbbVie and Gilead have had to respond.
- Merck will announce Q1 results on Thursday before the open. Consensus view is EPS of $0.85 of revenues of $9.47B.
Tue, Apr. 26, 11:56 AM
- China's Center for Drug Evaluation puts hepatitis C candidates on an accelerated review track with the aim of finally granting access to the drugs for its ~13M HCV-positive citizens. China was not part of the large-scale licensing effort by Gilead Sciences (GILD -0.9%) in 2015 which enabled a number of generics firms to manufacture and distribute Sovaldi (sofosbuvir) to certain emerging markets at a heavily discounted price. AbbVie (ABBV -0.3%), Merck (MRK -0.4%) and Bristol-Myers Squibb (BMY -0.2%) followed with licensing deals with The Medicines Patent Pool for African countries.
- Bristol-Myers, AbbVie, Johnson & Johnson (JNJ -0.6%) (via a joint venture called Xian Janssen) and Chinese firm Ascletis Pharmaceuticals all have submissions under review. No word on Gilead's application status is provided.
Wed, Apr. 20, 11:18 AM
- According to Leerink's Geoff Porges, drug makers appear to be taking little heed to politicians' outcries over high prices. In a research note, he says, "The price increases for established brands across our coverage have been substantial indeed. To the surprise of many investors, it now appears these price increases are likely to flow through to actual sales growth, with such growth more than offsetting any volume weakness in Q1 and resulting in significant positive revenue surprises for those companies when they report Q1 results."
- He cites Johnson & Johnson's (JNJ +0.8%) Q1 results released yesterday. Its total business was flat (+0.6%) but its pharmaceuticals unit was up 12.9%. His analysis showed as much as 90% of the list price increases are flowing through to reported sales, some as high as 100%.
- Over the past year, Amgen (AMGN +0.7%) increased its drug prices 8 - 28%, Gilead Sciences (GILD +0.9%) 10 - 18% for its HIV drugs and Biogen (BIIB -1.6%) 10 - 18%, according to Mr. Porges.
- Biogen reports tomorrow. Eli Lilly (LLY -0.3%), Baxalta (BXLT -1.4%), AbbVie (ABBV +0.9%), Celgene (CELG +0.4%), Bristol-Myers Sqibb (BMY +0.3%) and Shire (SHPG -1.6%) report next week. Pfizer (PFE +1%) and Merck (MRK -0.2%) report the week after. Amgen (AMGN +0.7%) is due to report shortly as is Gilead.
Mon, Apr. 18, 8:53 AM
- The FDA designates Merck's (NYSE:MRK) KEYTRUDA (pembrolizumab) a Breakthrough Therapy for the treatment classical Hodgkin lymphoma (cHL), the fourth BTD tag for the therapeutic.
- Breakthrough Therapy status provides for more intensive guidance from the FDA, the involvement of more senior agency personnel and a rolling review of the (supplemental) New Drug Application.
- KEYTRUDA was previously granted BTD status for advanced melanoma, advanced non-small cell lung cancer and advanced colorectal cancer.
Merck & Co., Inc. provides various health solutions through its prescription medicines, vaccines, biologic therapies, animal health, and consumer care products worldwide. It is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets vaccines and... More
Industry: Drug Manufacturers - Major
Country: United States
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