Jul. 15, 2014, 7:46 AM| 3 Comments
Jul. 14, 2014, 5:30 PM
Jul. 14, 2014, 1:19 PM
- Johnson & Johnson's (JNJ +0.2%) Janssen Pharmaceuticals submits an sNDA for an expanded indication for Invega Sustenna (paliperidone palmitate). The label change, if approved, would include data showing significantly delayed time to relapse in patients treated with Invega Sustenna compared to selected oral antipsychotic therapies in the treatment of schizophrenia.
- In a 444-patient clinical trial, whose time to treatment failure was the primary endpoint, Invega Sustenna patients' delay of relapse was 190 days longer compared to other oral antipsychotics. The results were statistically significant.
- The FDA first approved the product in July 2009 as a treatment for schizophrenia.
Jul. 11, 2014, 1:47 PM
- Dr. Andrew Brill had to recuse himself from the FDA's Obstetrics and Gynecology Devices Ad Comm meeting this week due to his relationship with Johnson & Johnson's (JNJ -0.6%) Ethicon unit. It paid Dr. Brill ~$213,000 last year in consulting fees.
- The Committee is meeting this week to discuss the future use of power morcellators used in hysterectomies. Some experts believe the devices assist the spread of cancer by disseminating undetected cancer cells as it divides and removes tissue. Ethicon markets such a device under the trade name Gynecare Morcellex.
Jul. 3, 2014, 8:28 AM
- In response to a request from the FDA, (TEVA) files a citizen petition (CP) on the approvability of generic versions of Copaxone (glatiramer acetate injection). The agency wanted a CP in order to facilitate public review and comment on new scientific data on gene expression. This will allow Teva to comment publicly on the views and opinions of others and will create an administrative record that the FDA may use as a basis for future decisions.
- Teva's CP provides new scientific data on gene expression and evidence to support arguments that active ingredient sameness, immunogenicity and bioequivalence in generic offerings are similar but not the same as Copaxone. The company says that competitive offerings should use the same gene expression markers and biological pathways to demonstrate sameness and be evaluated in full-scale clinical trials.
- One possible outcome of Teva's aggressive efforts to maintain a moat around Copaxone is that it may give it more empathy for branded drug makers when it goes after incumbent products with its own generic versions.
- Related tickers: (MNK) (ACT) (JNJ) (MYL) (MNTA) (NVS)
Jun. 27, 2014, 10:31 AM
- Janssen-Cilag International NV (JNJ -0.4%) submits a type II variation (EMA's version of an sNDA) to expand the label of Velcade (bortezomib) for use in combination with rituximab, cyclophosphamide, doxorubicin and prednisone for the treatment of adult patients with previously untreated Mantle Cell Lymphoma (MCL). Velcade is currently approved as a treatment, in combination with other agents, for Multiple Myeloma.
- In a clinical trial, the Velcade combination therapy demonstrated a statistically significant improvement in progression-free survival (PFS) of 59% (24.7 months vs. 14.4 months) compared to R-CHOP therapy.
Jun. 24, 2014, 8:43 AM
- Covidien (COV) files a patent infringement suit in the U.S. District Court in Connecticut against Ethicon Endo-Surgery (JNJ). It alleges that Ethicon's Harmonic ACE+7 Shears infringes on three COV patents. The same court ruled in favor of COV regarding the validity of the three patents in an earlier suit involving other Ethicon ultrasonic surgical products and awarded COV $175M. The award is under appeal.
Jun. 18, 2014, 9:15 AM
- Vertex Pharmaceuticals (VRTX) licenses its influenza drug candidate VX-787 to J&J (JNJ) unit Janssen Pharmaceuticals. Under the terms of the agreement, Vertex receives an upfront payment of $30M, additional development and commercial milestone payments and royalties on future sales.
- VX-787 works by directly inhibiting the replication of the flu virus. In a Phase 2a study, the drug met its primary endpoint of statistically significant improvements in viral and clinical measurements.
Jun. 12, 2014, 4:16 PM
- Privately-held biosimilar developer Epirus Biopharmaceuticals acquires Zalicus (ZLCS +38.9%) in an all-stock deal. The post-merger firm will be named Epirus Biopharmaceuticals. Current ZLCS shareholders will own ~19% of the combined enterprise. Their proportion could go down as low as 14% if Zalicus' cash position falls below $9M at closing.
- Epirus's pipeline includes biosimilars for Janssen's (JNJ -0.8%) Remicade, AbbVie's (ABBV -1.1%) Humira and Genentech's (RHHBY -0.6%) Avastin.
Jun. 12, 2014, 9:21 AM
- Taking advantage of a special waiver that allows it to deny routine coverage of drugs based on cost and efficacy, Oregon Health Plan intends to limit access to Gilead's (GILD) Sovaldi and J&J's (JNJ) Olysio. The combination therapy, which is becoming more and more popular among clinicians, costs $150,000 per regimen. Covering a third of the 7,000 OHP members with Hep C for Sovaldi alone ($84,000/regimen) would cost $196M. This would double its system-wide drug spending. Last year, the Plan spent a total of $377M for pharmaceuticals for all of its 600K members.
- In 2012, Governor John Kitzhaber agreed to cap OHP costs in exchange for $1.9B in federal aid over five years. If costs rise above 3.4%/year it must reimburse the feds hundreds of millions of dollars.
- The OHP situation is getting a lot of scrutiny because of the budget-busting consequences of paying for ultra-expensive drugs. Many observers hope its actions spur debate on how to curb prices without stifling innovation.
May. 29, 2014, 10:49 AM
- Johnson & Johnson (JNJ +0.1%) and Bausch & Lomb are among the companies fined 19.6 yuan ($3M) for price fixing in China's contact lens and eyeglass market. Chinese authorities have fined companies in other medical industries for price-related infractions as it grapples with its ballooning health care costs.
May. 22, 2014, 10:57 AM
- Executives at Johnson & Johnson's (JNJ -0.6%) $28.5B Medical Devices and Diagnostics segment meet with institutional investors today discuss the business and outline their plans to drive global growth.
- Key points include: ~$1.8B in R&D investments last year; a pipeline of more than 30 major product filings by the end of 2016; $6B in device sales; acquisition of Spectrum Vision enables the delivery of more than 85% of Acuvue contact lenses the same day or next day across all time zones in Russia; China operations grew 18% last year to $1.4B.
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May. 20, 2014, 5:07 PM
- The FDA approves Takeda's Entyvio (vedolizumab) for the treatment of moderate-to-severe ulcerative colitis and moderate-to-severe Crohn's disease in adult patients who have not responded to one or more standard therapies.
- Vedolizumab is an integrin receptor antagonist. Integrin receptors are proteins expressed on the surface of certain cells and function as bridges for cell-to-cell interactions. The mAb works by blocking the migration of circulating inflammatory cells across blood vessels and into areas of inflammation in the GI tract.
- Related tickers: (SHPG) (JNJ) (AZN) (BIIB) (ABBV)
May. 19, 2014, 11:32 AM
- In a survey of specialists, Research firm Decision Resources Group finds that Gilead's (GILD +1.3%) HCV treatment Sovaldi accounts for 50% of the patient share followed by J&J's (JNJ -0.3%) Olysio at 20%.
- The majority of Olysio prescriptions are being written for the off-label combination with Sovaldi with or without ribavarin. Trending analysis shows that the off-label prescribing for the combination has more than doubled with 30% of specialists reporting having at least some patients on the regimen.
- Hepatologists are more likely to prescribe the Sovaldi/Olysio combination than gastroenterologists or infectious disease specialists. The latter two have the majority of their HCV-1 patients on first-gen protease inhibitor therapy. The reason for the disparity appears to be awareness.
May. 16, 2014, 8:55 AM
- The European Commission approves J&J (JNJ) unit Janssen Pharmaceuticals' Olysio (simeprivir) for the treatment of Hepatitis C genotype 1 and 4 infection in combination with other medicines.
- Olysio is already approved for sale in the U.S., Japan, Canada and Russia. It will be available in the EU in 2H 2014.
- Related tickers: (GILD) (ABBV) (BMY) (MRK)
May. 15, 2014, 9:32 AM
- Actavis (ACT) and J&J (JNJ) unit Janseen Pharmaceuticals extend their supply and distribution agreement for Janssen's Concerta (methylphenidate hydrochloride extended-release tablets) to December 31, 2017. Janssen will continue to manufacture and supply all dosage strengths of the authorized generic product and Actavis will continue to market it in the U.S. and pay Janssen 50% of net sales.
- Under the terms of the contract, Actavis may pursue FDA clearance of its own ANDA for a generic version of the product and launch it at after 2017.
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Johnson & Johnson is a holding company, which is engaged in the research and development, manufacture and sale ofproducts in the health care field within its Consumer, Pharmaceutical and Medical Devices, and Diagnostics business segments.
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