Wed, Aug. 12, 7:35 AM
- Reckitt Benckiser (OTCPK:RBGPF) (OTCPK:RBGLY) receives regulatory clearance from the UK's Competition and Markets Authority (CMA) to purchase Johnson & Johnson's (NYSE:JNJ) K-Y intimate lubricant business with the proviso that it license the brand to a third party for eight years. During this period, the company selling K-Y would create its own brand, after which Reckitt would resume control of K-Y.
- Reckitt agreed to buy K-Y last year but encountered opposition from UK authorities who said the deal would reduce competition and result in higher prices for consumers. The CMA asked the company put forward measures to allay their concerns, but its initial proposals were unsuccessful.
- The company's plan to purchase the K-Y business in New Zealand was also blocked due to anti-competitive concerns. Reckitt chief Rakesh Kapoor isn't too concerned since the bulk of K-Y sales come from the U.S., Canada and Brazil.
- Under Mr. Kapoor, Reckitt is moving into higher margin consumer health products. The strategy appears to be working. H1 comps were up 13%.
Fri, Aug. 7, 8:14 AM
- A new class of cancer therapeutics has been rekindled of late led by Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY). They are called immune system accelerators, antibodies that target a protein called 4-1BB, also known as CD137.
- When the immune system's T-cells and natural killer (NK) cells identify cancer cells, the 4-1BB protein appears on their surfaces which accelerates their attack. The protein was discovered over 20 years ago, but its development was abandoned in 2008 after early-stage studies done by Bristol showed signs of liver damage. Scientists eventually realized that lower doses of 4-1BB, given at the right time, could elicit the desired anti-cancer effect without the unwanted toxicity. Early results have been impressive. A 38-subject study done by Pfizer, 40% of patients with follicular lymphoma and a third of those with mantle cell lymphoma experienced a reduction in cancer with no serious side effects.
- Phase 1 studies are underway assessing combinations of immune checkpoint inhibitors, like Roche's (OTCQX:RHHBY) Rituxan (rituximab) and accelerators. Studies are planned for Pfizer's 4-1BB candidate in combination with Herceptin (trastuzumab) and the combination of Bristol's 4-1BB candidate, urelumab, with Eli Lilly's (NYSE:LLY) Erbitux (cetuximab). Bristol in currently enrolling patients in five Phase 1 studies in multiple myeloma, lymphomas and solid tumor cancers. Pfizer is planning trials with an immunotherapy from Kyowa Hakko Kirin and Merck's (NYSE:MRK) Keytruda (pembrolizumab).
- Johnson & Johnson (NYSE:JNJ) and AbbVie (NYSE:ABBV) are a step behind doing preclinical work on their accelerator candidates.
Fri, Jul. 24, 9:01 AM
- Janssen (NYSE:JNJ) submits a supplemental New Drug Application (sNDA) to the FDA seeking new labeling for its HCV-1 drug Olysio (simprevir). The current label specifies a 12-week treatment period of Olysio, in combination with Gilead's (NASDAQ:GILD) Sovaldi (sofosbuvir), for patients without cirrhosis and 24 weeks for those with cirrhosis. The new label, if approved, will shorten the treatment periods to eight and 12 weeks, respectively. The shorter durations of treatment are supported by results from the OPTIMIST-1 and OPTIMIST-2 Phase 3 studies.
- Simprevir, an NS3/4A protease inhibitor, was jointly developed with Stockholm, Sweden-based Medivir (OTC:MVRBY) (OTC:MVRBF), which retains the marketing rights in the Nordic countries.
- Previously: Phase 3 results show HCV-1 cure rates as high as 97% for Olysio + Sovaldi (April 23)
Tue, Jul. 21, 4:23 PM
- Results from a Phase 3 clinical trial, Study 109, assessing Gilead Science's (GILD -0.4%) next generation offering for the treatment of HIV-1 infection showed that it was non-inferior (no worse than) to tenofovir disoproxil fumarate (TDF)-based regimens such as Stribild at week 48. Additionally, the study demonstrated statistical superiority among patients with HIV-1 RNA levels less than 50 copies/mL. The data were presented at the eighth IAS Conference on HIV Pathogenesis, Treatment & Prevention in Vancouver, Canada.
- The product candidate is a once-daily single tablet combination of elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir alafenamide 10 mg (E/C/F/TAF). The value proposition of the new combo pill is comparable antiviral efficacy to TDF at one tenth the dose which mitigates unwanted stress on the bones and kidneys. This makes it a more desirable therapeutic option for long term use.
- Data from Study 109 show that patients receiving E/C/F/TAF experienced a cure rate (SVR12) of 97% compared to 93% for the TDF cohort. The rates of virologic failure were 1.0% for TAF versus 1.3% for TDF. General safety was similar.
- The company has three NDAs under review at the FDA for TAF products, one for two fixed-dose combination F/TAFs (200 mg/10 mg and 200/25 mg), one for E/C/F/TAF and one for the combination of emtricitabine 200mg, TAF and Janssen's (NYSE:JNJ) rilpivirine 25 mg (R/F/TAF). The FDA has announced PDUFA dates for E/C/F/TAF (November 5) and F/TAF (April 7, 2016). The NDA for R/F/TAF was submitted on July 1 so a PDUFA won't be assigned until the agency accepts the application for review.
Mon, Jul. 20, 12:06 PM
Wed, Jul. 15, 7:01 AM
- The Oxford Vaccines Group initiates a Phase 2 clinical trial evaluating the Ebola prime-boost vaccine regimen that combines Bavarian Nordic's (OTCPK:BVNRY) (OTC:BVNKF) MVA-BN Filo vaccine with Janssen Pharmaceutical's (NYSE:JNJ) Ad26.ZEBOV vaccine. The first of the 612 healthy adult volunteers have received their initial dose in the UK/France-based study.
- A second Phase 2 trial in 1,200 volunteers will commence in Africa in Q3.
Tue, Jul. 14, 8:26 AM
- Johnson & Johnson (NYSE:JNJ) Q2 results ($M): Total Revenues: 17,787 (-8.8%); Consumer: 3,483 (-7.0%); Pharmaceutical: 7,946 (-6.6%); Medical Devices & Diagnostics: 6,358 (-12.2%).
- Revenue by Region: U.S.: 8,911 (-2.4%); Europe: 4,151 (-17.9%); Western Hemisphere ex-U.S.: 1,501 (-19.4%); Asia Pacific & Africa: 3,224 (-6.4%).
- Total revenue growth has decelerated over the past four quarters: +9.1%, +5.1%, -0.6%, -4.1%, -8.8%.
- Pharma unit revenue growth has decelerated the past four quarters: +21.1%, +18.1%, +9.6%, +3.0%, -6.6%.
- Operating earnings growth has also decelerated over the past four quarters: +17.8%, +14.4%; -3.1%; -5.3%; -17.6%.
- EPS guidance raised to $6.10 - 6.20.
Tue, Jul. 14, 7:47 AM
Tue, Jul. 14, 7:14 AM
- Epirus Biopharmaceuticals (NASDAQ:EPRS) inks a collaboration deal with Polpharma Group for certain Epirus biosimilar candidates, including BOW015 [reference product: J&J's (NYSE:JNJ) Remicade (infliximab)], BOW050 [reference product: AbbVie's (NYSE:ABBV) Humira (adalimumab)] and BOW070 [reference product: Roche's (OTCQX:RHHBY) Actemra (tocilizumab)].
- Polpharma is a leading generics firm based in Poland with annual sales of ~$1B.
- Under the terms of the agreement, both companies with jointly fund clinical development and will collaborate on regulatory filings in the specified territories. Epirus will be responsible for process development, scale-up and manufacturing while Polpharma will be responsible for commercialization. Clinical development costs and eventual operating profit will be split 51/49 in favor of Polpharma. Polpharma will contribute ~$30M toward development costs and cover product launch costs across the three programs.
- Epirus retains commercial rights in Switzerland, Norway, Austria, Belgium, Denmark, Finland. Luxembourg, the Netherlands and Sweden. It also retains commercial rights in North America and other global markets not covered in the agreement.
Mon, Jul. 13, 5:30 PM
Fri, Jul. 10, 8:12 AM
- The European Commission approves AbbVie's (NYSE:ABBV) Imbruvica (ibrutinib) for the treatment of Waldenstrom's macroglobulinemia (WM), a rare slow-growing blood cancer, in adult patients who have received at least one prior therapy or as first treatment in patients unsuitable for chemo-immunotherapy. The action triggers a $20M milestone payment from Janssen Biotech (NYSE:JNJ).
- The FDA approved Imbruvica for WM in January. It is being jointly developed and commercialized in the U.S. by Pharmacyclics and Janssen Biotech. Janssen-Cilag International NV will market it in Europe and its affiliates will do so in the Middle East, Africa and ROW.
- Imbruvica is also cleared in Europe for the treatment of adult patients with relapsed/refractory mantle cell lymphoma and adult patients with chronic lymphocytic leukemia who have received at least one prior therapy or first line use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
- WM affects about 3 people per million. About 1,000 new cases are diagnosed each year in the U.S. with a comparable number in Europe.
Thu, Jul. 9, 2:03 PM
- Janssen Biotech (JNJ +0.9%) finishes the rolling submission of its Biologics License Application (BLA) for Breakthrough Therapy-designated daratumumab for the treatment of multiple myeloma patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) or an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The application includes a request for Priority Review. If granted, it will shorten the review clock to six months.
- The completion of the filing triggers a $15M milestone payment to antibody discoverer Genmab (OTCPK:GMXAY) (OTC:GNMSF). In August 2012, Genmab granted Janssen an exclusive global license to develop, manufacture and commercialize the product.
- Daratumumab is an investigational human IgG1k monoclonal antibody that binds to the transmembrane ectoenzyme CD38, found on the surface of multiple myeloma cells. Once bound, it induces rapid tumor cell death.
Wed, Jul. 8, 2:22 PM
- Teva Pharmaceutical Industries (TEVA -1.3%) launches its generic version of Janssen's (JNJ -0.8%) Axert (almotriptan malate), 6.25 mg and 12.5 mg, in the U.S. for the acute treatment of migraine. According to IMS, Axert generated $31M in sales for the 12-month period ending in March.
- Teva markets over 375 generic medicines.
Mon, Jul. 6, 8:53 AM
- In a big win for Hospira (NYSE:PFE), France's Assistance Publique - Hopitaux de Paris (AP-HP) has signed on to buy its biosimilar version of Janssen's (NYSE:JNJ) Remicade (infliximab) after Hospira offered it a healthy 45% discount over the branded version. AP-HP covers almost 25% of the French population, although it only projects spending ~6M euros per year for Hospira's product, called Inflectra.
- Remicade has annual sales in Europe of ~2B euros ($2.2B).
Wed, Jul. 1, 4:52 PM
- Gilead Sciences (NASDAQ:GILD) submits a New Drug Application (NDA) to the FDA seeking approval for a once-daily single tablet regimen for the treatment of patients at least 12 years old with HIV-1 infection. The drug combines Gilead's emtricitabine 200 mg and tenofovir alafenamide (TAF) 25 mg with Janssen Sciences Ireland's (NYSE:JNJ) rilpivirine (Edurant) 25 mg (R/F/TAF).
- The submission is Gilead's third TAF-related filing in the past 12 months. In November 2014 it filed an NDA for a once-daily single tablet E/C/F/TAF (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/TAF 10 mg). In April of this year, it filed another NDA for two doses of a fixed-dose combination of F/TAF (emtricitabine 200 mg/tenofovir 10 mg/20 mg). The PDUFA dates for E/C/F/TAF and F/TAF are November 5, 2015 and April 7, 2016, respectively. Gilead's Marketing Authorization Applications (MAAs) for both are currently under review in Europe.
Fri, Jun. 26, 12:06 PM
- As expected, the European Commission approves the use of Janssen's (JNJ +0.4%) Simponi (golimumab) for the treatment of adult patients with severe, active non-radiological axial spondyloarthritis. In May, CHMP issued a positive opinion recommending clearance.
- Previously: Europe Ad Comm gives thumbs up to new indication for Simponi (May 26)
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