Archive for the ‘Pharmacyclics’ Category
Dec
12
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Videos by John Carroll
Anyone looking for a solid reason why J&J's Janssen would pay $150 million upfront to partner on Pharmacyclics' experimental blood cancer drug need look no further than the leukemia data the biotech had to offer analysts over the weekend.
Pharmacyclics ($PCYC) reported on Sunday that the 10-month follow-up data on its low-dose formulation of PCI-32765, a Btk inhibitor, looks better than the six-month data it's gathered in a small Phase Ib/II study. A total of 70% of the 61 chronic lymphocytic leukemia patients in the trial demonstrated a significant response, compared to 48% at the six-month mark. Progression-free survival hit 90% at six months,
All of the patients had failed at least two standard therapies for leukemia. The response rate in the high-dose group hit 44%. Lead author Dr. John Byrd of Ohio State called the data "phenomenal."
"In the 15 years I've been practicing as a CLL-specific specialist, this is by far the most phenomenally active drug for refractory CLL patients in terms of response and durability and tolerability," Byrd told HemOnc Today. "Eighty-six percent of people receiving this drug are progression free at 1 year. Given the durability and the potential that patients can stay on therapy for an extended period of time without adverse events, it's likely this is going a paradigm-shifting drug."
J&J ($JNJ) presumably agreed with that upbeat assessment. On Friday Janssen committed an old-fashioned blockbuster upfront to buy into the program, demonstrating once again that the Big Pharma company is willing to dig down into its very deep pockets to jump into a late-stage program that has been significantly de-risked. J&J will now help orchestrate a range of Phase III studies for the treatment.
- here's the Reuters story
- get the article from HemOnc Today
Related Articles:
Updated: J&J locks in blood cancer compound in $975M pact
Pharmacyclics snares $39.5M development deal
Dec
12
Posted under
Blog,
blood cancer,
chronic lymphocytic leukemia,
Companies,
Diagnostics,
Funding,
leukemia,
Medical Devices,
Medical Supply,
PCI-32765,
Pharmaceuticals,
Pharmacyclics,
Startups,
Universities,
Videos by John Carroll
Anyone looking for a solid reason why J&J's Janssen would pay $150 million upfront to partner on Pharmacyclics' experimental blood cancer drug need look no further than the leukemia data the biotech had to offer analysts over the weekend.
Pharmacyclics ($PCYC) reported on Sunday that the 10-month follow-up data on its low-dose formulation of PCI-32765, a Btk inhibitor, looks better than the six-month data it's gathered in a small Phase Ib/II study. A total of 70% of the 61 chronic lymphocytic leukemia patients in the trial demonstrated a significant response, compared to 48% at the six-month mark. Progression-free survival hit 90% at six months,
All of the patients had failed at least two standard therapies for leukemia. The response rate in the high-dose group hit 44%. Lead author Dr. John Byrd of Ohio State called the data "phenomenal."
"In the 15 years I've been practicing as a CLL-specific specialist, this is by far the most phenomenally active drug for refractory CLL patients in terms of response and durability and tolerability," Byrd told HemOnc Today. "Eighty-six percent of people receiving this drug are progression free at 1 year. Given the durability and the potential that patients can stay on therapy for an extended period of time without adverse events, it's likely this is going a paradigm-shifting drug."
J&J ($JNJ) presumably agreed with that upbeat assessment. On Friday Janssen committed an old-fashioned blockbuster upfront to buy into the program, demonstrating once again that the Big Pharma company is willing to dig down into its very deep pockets to jump into a late-stage program that has been significantly de-risked. J&J will now help orchestrate a range of Phase III studies for the treatment.
- here's the Reuters story
- get the article from HemOnc Today
Related Articles:
Updated: J&J locks in blood cancer compound in $975M pact
Pharmacyclics snares $39.5M development deal
Dec
09
Posted under
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blood cancer,
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Diagnostics,
Funding,
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Medical Supply,
PCI-32765,
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Videos by Ryan McBride
A unit of Johnson & Johnson ($JNJ) has made big bet on the future of developer Pharmacyclics' ($PCYC) experimental compound in midstage testing for blood cancers, shelling out $150 million in upfront money to seal the deal and promising up to $825 million in milestone payments.
While the pact may be a small piece of the pipeline puzzle at the healthcare giant J&J, it's a significant step forward for Sunnyvale, CA-based Pharmacyclics, which has no products on the market and failed to get FDA approval of a previous cancer drug. Pharmacyclics now has a deep-pocketed development partner to advance PCI-32765, a Bruton's tyrosine kinase (Btk) inhibitor that targets the BCR signaling pathway linked to the growth and spread of certain types of blood cancers. The developer is keeping for itself rights to the drug for inflammation and immune-mediated ailments.
The drug has made it as far as Phase II testing, making the sizable $150 million down payment from J&J's Janssen Biotech worth noticing, as many upfront payments for midstage assets haven't been so rich. Pharmacyclics is now trialing the small molecule drug in non-Hodgkin's lymphoma, chronic lymphocytic leukemia and multiple myeloma. With its big partner on board, the developer will pay for 40% of development costs of the program and J&J will handle the rest. Bloomberg reports that the companies will split worldwide profits from potential sales of the drug right down the middle.
Some investors apparently weren't thrilled with the terms of the deal for Pharmacyclics, sending the company's shares down by more than 15% as of 12:50 pm ET on Friday.
"The agreement with Pharmacyclics is an opportunity to bring a new form of oral therapy to patients with B-cell malignancies," said Dr. William Hait, global therapeutic head of oncology for Janssen, in a statement. "PCI-32765 is an innovative compound, with broad applicability and the potential to help a large number of patients with B-cell malignancies."
For Pharmacyclics, PCI-32765 gives the company another chance for FDA approval after the agency shot down an application for a market green light on a previous cancer therapy, Xcytrin, with a refuse to file letter in 2007. Now that J&J is backing PCI-32765's development, there's likely to be some extra attention on the program's midstage data that are to be presented at the upcoming American Society of Hematology meeting.
- here's Pharmacyclics' release
- see J&J's release
- and Bloomberg's report
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Pharmacyclics snares $39.5M development deal
Janssen inks $800M discovery deal for Molecular Partners' small protein tech