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News Breaks
July 31, 2014
16:17 EDTJNJ, PCYCPharmacyclics says $60M Janssen milestone payment to be recognized in Q3
As previously announced on July 28, that the FDA granted IMBRUVICA regular approval for the treatment of patients with CLL who have received at least one prior therapy, and for the treatment of CLL patients with deletion of the short arm of chromosome 17, including treatment naive and previously treated del 17p CLL patients. This approval of IMBRUVICA in del 17p CLL triggers $60M in milestone payments to Pharmacyclics (PCYC) under its agreement with Janssen (JNJ), which will be recognized as revenue in the third quarter of 2014. To date, in addition to the upfront payment of $150M, Pharmacyclics has earned milestone payments of $505M under the agreement. It may receive up to an additional $320M in development, regulatory and approval milestone payments, however, clinical development entails risks and the company has no assurance as to whether or when the milestone targets might be achieved.
News For PCYC;JNJ From The Last 14 Days
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December 22, 2014
09:02 EDTPCYCPharmacyclics announce supdate on Imbruvica WM submission
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08:01 EDTJNJAASLD publishes new recommendations for treating Hepatitis C
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06:33 EDTJNJSevion announces antibody discovery collaboration with Johnson & Johnson
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06:29 EDTJNJGilead drops 4% after Express Scripts picks AbbVie for hepatitis C
Shares of Gilead (GILD) are moving lower in pre-market trading after Express Scripts (ESRX) spokesman Brian Henry told CNBC's Meg Tirrell and other news outlets that the pharmacy benefits manger will exclusively offer AbbVie's (ABBV) recently approved hepatitis C regimen Viekira Pak at a "significant discount" starting Jan. 1. Express Scripts will no longer offer competing drugs from Gilead and Johnson & Johnson (JNJ). Shares of AbbVie are rising 6% to $71.50 in pre-market trading while Gilead is down 4% to $104.15. AbbVie discovered part of the Viekira Pak regimen via its ongoing collaboration with Enanta Pharmaceuticals (ENTA). Shares of Enanta are up 7% to $49.96 in pre-open trading.
06:05 EDTJNJMacroGenics ennters collaboration, license agreement with Janssen
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05:44 EDTJNJExpress Scripts to offer AbbVie hepatitis C drug exclusively, CNBC reports
Express Scripts (ESRX) will offer AbbVie's (ABBV) just approved hepatitis C regimen Viekira Pak at a "significant discount" starting Jan. 1, while excluding competing drugs from Gilead (GILD) and Johnson & Johnson (JNJ), CNBC's Meg Tirrell reports, citing comments from the pharmacy benefits manager's spokesman Brian Henry. Reference Link
December 19, 2014
11:08 EDTJNJJohnson & Johnson receives positive CHMP opinion to extend Velcade indication
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December 17, 2014
09:04 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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09:02 EDTJNJHalozyme enters collaboration pact with Janssen for ENHANZE Technology
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08:06 EDTJNJInovio appoints Zane Yang as VP, Clinical Development, Oncology
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December 16, 2014
07:20 EDTJNJGeron announces early HSR clearance for collaboration with Janssen
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December 12, 2014
14:01 EDTJNJGenOn Energy to receive $3M milestone payment in Janssen collaboration
Genmab announced it has reached a milestone in its DuoBody technology platform collaboration with Janssen Biotech (JNJ), triggering a $3M payment. The milestone payment is for pre-clinical progress with a DuoBody product candidate targeting cancer. Today's news will not impact Genmab's 2014 financial guidance.
08:01 EDTPCYCPiper predicts two large-cap biotechs could be acquired in 2015
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December 10, 2014
09:18 EDTPCYCPharmacyclics data 'impressive,' says Roth Capital
Roth Capital believes that Pharmacyclics presented important updates at the ASH conference on Imbruvica. The firm thinks the data "all point to Imbruvica's potency in hematological malignancies." It reiterates a $188 price target and Buy rating on the shares.
December 9, 2014
05:50 EDTJNJ, PCYCPharmacyclics data demonstrates safety, durability response
New, 27-month IMBRUVICA median follow-up data announced by Pharmacyclics (PCYC) support the use of IMBRUVICA over longer periods of time in patients with relapsed/refractory mantle cell lymphoma, or MCL, an aggressive type of lymphoma. More than 30% of IMBRUVICA patients remained progression-free after two years with no new or unexpected adverse events occurring during that time. Nearly half of the 111 patients treated were still living at the time of the data analysis. A second Phase II trial looked at IMBRUVICA's efficacy and safety as a single-agent treatment for MCL patients who previously had received rituximab combination therapy and at least two cycles of bortezomib. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:43 EDTPCYC, JNJPharmacyclics reports IMBRUVICA data shows 84% PFS rate at one year
Pharmacyclics (PCYC) announced new, longer term data in IMBRUVICA patients with relapsed/refractory chronic lymphocytic leukemia, or CLL, including high-risk CLL patients with deletion 17p. Results from the Phase III RESONATE trial demonstrated an 84% progression-free survival, or PFS, rate in all patients with previously treated CLL or small lymphocytic lymphoma, or SLL, who received IMBRUVICA and a 94% PFS rate in patients who received only one prior therapy at 12 months. Separately, follow-up data was reported from Phase II RESONATE-17, or PCYC-1117, the largest prospective trial dedicated to studying CLL or SLL patients with del 17p. The data showed that IMBRUVICA was associated with an 83% overall response rate, or ORR, at a median follow up of 11.5 months. At 12 months, the estimated PFS was 79%. These results and additional data were presented here at the 56th American Society of Hematology, or ASH, Annual Meeting, highlighting IMBRUVICA's sustained efficacy in relapsed/refractory patients who have received at least one prior therapy. IMBRUVICA combination therapy resulted in an 88% overall response rate in MCL patients with a complete response rate of 40%. IMBRUVICA is jointly developed and commercialized by Pharmacyclics and Janssen Biotech, a unit of Johnson and Johnson (JNJ).
05:27 EDTPCYC, JNJPharmacyclics IMBRUVICA Phase II combination data shows positive profile
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December 8, 2014
13:45 EDTPCYCTG Therapeutics says TG-1101 well tolerated in Phase 2 study
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08:32 EDTPCYCTrout Group to hold events at ASH 2014
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