On June 9, 2016 AbbVie (NYSE: ABBV), a global biopharmaceutical company, reported data on its investigational medicine venetoclax, a B-cell lymphoma -2 (BCL-2) inhibitor, and duvelisib, an investigational phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma inhibitor, at the 21st European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, June 9-12, in Copenhagen, Denmark (Press release, AbbVie, JUN 9, 2016, View Source [SID:1234513157]). Data will be presented in some of the most common hematological malignancies, including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), acute myeloid leukemia (AML) and follicular lymphoma.

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"BCL-2 inhibition is an exciting new mechanism of action and the data that will be presented demonstrate venetoclax’s potential across a range of blood cancers," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "The data underscore AbbVie’s growing hematology portfolio and our commitment to changing the way blood cancer is treated with innovative new treatment options."

The 10 venetoclax abstracts and one duvelisib abstract that will be presented at EHA (Free EHA Whitepaper) demonstrate how AbbVie is utilizing its deep expertise to explore novel mechanisms of action and administration to disrupt cancer development and growth in blood cancers.

AbbVie abstracts:

Venetoclax in CLL

Impact of adding rituximab to venetoclax on the rate, quality and duration of response in patients with relapsed/refractory chronic lymphocytic leukemia: a cross-study multivariable analysis; Roberts et al.; Abstract P209; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
Durable treatment-free remission and effective retreatment in patients with relapsed/refractory chronic lymphocytic leukemia who achieved a deep response with venetoclax combined with rituximab; Brander et al.; Abstract P223; Poster Session; June 10, 2016; 5:15-6:45 p.m. CET
Safety, efficacy and immune effects of venetoclax 400 mg daily in patients with relapsed chronic lymphocytic leukemia; Anderson et al.; Abstract P591; Poster Session; Saturday, June 11, 2016; 5:30-7:00 p.m. CET
Integrated safety analysis of venetoclax monotherapy in chronic lymphocytic leukemia; Davids et al.; Abstract P225; Poster Session; Friday, June 10 2016; 5:15-6:45 p.m. CET
Venetoclax is active in CLL patients who have relapsed after or are refractory to ibrutinib or idelalisib; Coutre et al.; Abstract P599; Poster Session; Saturday, June 11 2016; 5:30-7:00 p.m. CET
Interim quality of life results with venetoclax (ABT-199/GDC-0199) monotherapy in patients with relapsed/refractory del(17p) chronic lymphocytic leukemia; Wierda et al.; Abstract P426; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
Venetoclax in AML

Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ?65 years ineligible for standard induction therapy; Pollyea et al.; Abstract P192; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged ?65 years with acute myelogenous leukemia; Lin et al.; Abstract E911; ePOSTER
Venetoclax in MM

Phase 1b study of venetoclax combined with bortezomib and dexamethasone in relapsed/refractory multiple myeloma; Moreau et al.; Abstract P272; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
Phase 1 study of venetoclax monotherapy for relapsed/refractory multiple myeloma; Kumar et al.; Abstract S814; Oral Presentation; Sunday, June 12, 2016; 8:15-8:30 a.m. CET
Duvelisib in Follicular Lymphoma

Preliminary safety, pharmacokinetics, and pharmacodynamics of duvelisib plus rituximab or obinutuzumab in patients with previously untreated CD20+ follicular lymphoma; Casulo et al.; Abstract P319; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
Meeting abstracts are available at www.ehaweb.org.

For more information about CLL, please visit View Source

About Venetoclax

Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various blood cancer types.[1],[2],[3],[4] The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be over expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein.[5] Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of relapsed/refractory chronic lymphocytic leukemia (CLL), along with studies in several other cancers. AbbVie and Genentech will co-promote venetoclax in the U.S.; however, AbbVie has exclusive rights to venetoclax outside of the U.S.

About Duvelisib

Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells.[6] PI3K signaling may lead to the proliferation of malignant B-cells, and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.[6],[7] ,[8] AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and developing duvelisib in various cancer types.

Duvelisib is being evaluated in several studies, including a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma,[9] a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma,[10] and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia.[11] Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

On June 08, 2016 Oncothyreon Inc. (NASDAQ:ONTY), a clinical-stage biopharmaceutical company, reported that the Company is changing its name to Cascadian Therapeutics, Inc. and will trade on the NASDAQ Global Select Market under the new ticker symbol "CASC," effective at market open on June 9, 2016 (Press release, Oncothyreon, JUN 8, 2016, View Source [SID:1234513127]).

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The new name reflects the change in the Company’s focus from therapeutic vaccines to advancing targeted treatments for cancer. The Company’s lead product candidate, ONT-380, is an orally bioavailable, highly selective small molecule HER2 inhibitor being developed as a combination therapy to treat HER2+ advanced or metastatic breast cancer.

"We chose to implement a new name to emphasize our organization’s transformation and vision for the future," said Scott Myers, President and CEO of Cascadian Therapeutics. "By incorporating the imagery of the Cascade Mountains, our goal was to highlight our Company’s heritage, but more importantly, to underscore our transition away from therapeutic vaccines to developing innovative targeted therapies for cancers, with a lead indication for metastatic HER2+ breast cancer. HER2CLIMB, our Phase 2 randomized, double-blind, placebo-controlled trial, was also named in the spirit of our mission to improve outcomes in this disease. We look forward to providing an update on this important program at our upcoming R&D Day."

On June 14th at 2 p.m. Eastern, the Company will present updated data from the ongoing "Triplet" Phase 1b trial, in addition to the future product development plans for ONT-380, at the Company’s R&D Day in New York City. The webcast will be available on the Events and Presentations Page of the Company’s website at www.cascadianrx.com.

No action is required by stockholders with respect to the name change. The Company’s common stock has been assigned a new CUSIP number of 14740B 101 in connection with the name change. Outstanding stock certificates are not affected by the name change and will not need to be exchanged.

On June 8, 2016 Sanofi today reported that it has filed an investor presentation with the U.S. Securities and Exchange Commission ("SEC") in connection with its proposed acquisition of Medivation, Inc. (NASDAQ: MDVN) (Press release, Sanofi, JUN 8, 2016, View Source [SID:1234513242]). This presentation is available on the Investor Relations section of Sanofi’s website.

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Among other things, the presentation notes:
The proposed transaction would provide compelling strategic and financial benefits for Sanofi and Medivation shareholders;

Sanofi’s proposal is not subject to any financing condition and the company is confident in its ability to receive all necessary regulatory approvals;

Combining with Medivation would accelerate Sanofi’s strategic priority of rebuilding a competitive position in oncology;

Sanofi has stated on several occasions that if Medivation were to engage and provide information, it would be in a position to increase its offer and is confident that it would be able to offer significant additional value;

Sanofi is willing to enter into a customary confidentiality agreement with Medivation, which would include a reasonable standstill to give time for Medivation to conduct a sale process;

The consent solicitation process allows Medivation shareholders to demonstrate support for a transaction by removing and replacing the Medivation Board with directors committed to acting in the best interest of maximizing value for Medivation shareholders;

Sanofi believes there is a clear path to completion: the record date to determine Medivation shareholders entitled to give their written consent has been established as June 1, 2016; Sanofi expects the initial Hart-Scott-Rodino (HSR) waiting period to expire on June 13, 2016; Sanofi anticipates filing definitive consent solicitation materials in mid-June 2016; and Sanofi signed a consent on
June 3, 2016 for the shares it owns in Medivation and therefore expects that the 60-day consent solicitation period will conclude no later than August 1, 2016; and

Sanofi believes that Medivation’s shareholders overwhelmingly support the sale of Medivation and want Medivation to engage with Sanofi.

On June 8, 2016 Enzo Biochem, Inc. (NYSE:ENZ) reported results for the third fiscal quarter and nine months ended April 30, 2016, with strong across the board advances (Filing, Q3, Enzo Biochem, 2016, JUN 8, 2016, View Source [SID:1234513138]).

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Highlights

Enzo Clinical Labs revenues grew by 16% over the prior year period reflecting increased throughput activity and focus on molecular diagnostics, now accounting for approximately 50% of its revenues.
Enzo Life Sciences revenues grew 22% sequentially over the prior quarter as domestic sales improved and the focus on higher margin reagents and other products yielded favorable results.
Total revenues advanced 10%, gross margins increased and net loss was reduced sharply.
Liquidity continues to improve, with the cash on hand today increasing to over $50 million, as compared to $18.1 million at the close of fiscal 2015.

Operating results for the Company’s third fiscal quarter ended April 30, 2016 continued to benefit from Enzo’s strategic management plan, emphasizing: esoteric diagnostic testing services, development of competitive genetic-based diagnostic cost-effective product platforms for use in-house and for sale nationwide, higher margin life science products, and increasing market share based on high quality diagnostic services, including expanding portfolio of women’s health products.
Approval of the new Candidiasis assay marks the third such approval in roughly a year, demonstrating Enzo’s strength in developing high quality proprietary assays. Enzo’s technology pipeline is robust, with other assays soon to be submitted for regulatory approval.
Subsequent to the end of the third quarter, Enzo announced that its subsidiary, Enzo Life Sciences, Inc., had reached a settlement with Life Technologies Corporation, a subsidiary of Thermo Fisher Scientific Inc. (TMO), resulting in a $35 million payment to Enzo, which is included in current cash balance.

Barry Weiner, President, Commented:

"This has been another quarter of significant progress for Enzo, as we continue to execute on our strategic plan. Again this quarter we demonstrated strong financial results and benefits of our integrated operating structure. The Clinical Labs Division remains on a solid growth trend, with molecular diagnostics increasingly predominant in its activities, as physician-clients recognize its unique capabilities and especially the Lab’s ability to provide services, assays and tests, particularly in the realm of women’s health issues. Enzo’s program to develop new tests for our AmpiProbe, FlowScript and other platforms is successfully moving forward rapidly, underscored by the New York State Department of Health’s conditional approval just three months after submission of our AmpiProbe Candidiasis assay, which follows similar authorization in the past year or so for our HCV and FlowScript assays.

"Meanwhile, Life Sciences is achieving improved results following several challenging quarters, during which it has aggressively moved to reposition itself by narrowing its product mix to concentrate on improved profitability, while also adding staff more experienced with the operations. We have become a specialized assay supplier as part of our integrated strategic plan to deliver highly efficient, cost effective diagnostics and assays for our own use and sale to independent labs.

"The proprietary platforms and accompanying assays, in addition to being highly cost effective in this challenging reimbursement environment, provide more sensitive diagnostics and allow for multiple testing of specimens, saving expenses and reducing patient discomfort. The three recently approved assays are part of a broad line of lower cost diagnostic products under development by Enzo to address the critical needs of clinical laboratories resulting from increasing pressure from steadily declining reimbursement rates. In addition to selling these highly effective and compatible platforms and their assays, we are positioning ourselves as a "go to" reference lab for independent labs nationwide with costs that we anticipate will be lower for them than doing so on their own.

From an operating viewpoint, we are effectively containing expenses, despite the necessity to expand sales, research and production staffs as we broaden our footprint. Legal expenses have been trending down, though one case remains on the trial docket in New York Federal Court. Our efforts to prevail on patent infringements in the Delaware court have thus far proved satisfactory, with seven cases still pending. The results are evident in our strong cash position, which ensures our ability to forcefully build our positioning and marketing of proprietary amplification and detection platforms, and their related assays. Recent patent litigation settlements further highlight the importance of our Company’s intellectual property, giving us a decided advantage in being able to further assay development independently, while adding to our financial strength and ability to capitalize on our goals."

3Q16 Results

With both Enzo Clinical Labs and Enzo Life Sciences posting positive revenue gains, total revenues increased to $26.4 million, from $24.0 million a year ago, a 10% increase. Cost of goods was approximately even year over year based on a percentage of revenues. Gross margin improved $1 million, or 9%, to $11.4 million, while gross profit as a percentage of revenue essentially remained even at 43.3% and 43.7%, respectively. Selling, general and administrative expenses (SG&A) increased slightly, to $10.9 million, from $10.2 million, reflecting increased selling expenses and higher Lab related costs due to new business, but as a percentage of revenues, SG&A improved to 41%, from 42% a year ago. Legal expenses declined 17%, to $1.6 million, although year ago results also reflected approximately $0.2 million in net legal settlements. There were no legal settlements in the fiscal 2016 third quarter.

Net loss amounted to ($2.1) million, compared to a year ago net loss of ($2.9) million, a $0.8 million improvement. Basic and fully diluted per share loss equaled ($0.05), versus ($0.06) last year. On a non-GAAP basis, the net loss per fully diluted share was ($0.04) compared to ($0.07) per fully diluted share in the prior year period. The EBITDA loss (earnings before interest, taxes, depreciation and amortization), a non GAAP measure, improved by approximately $0.9 million, to $1.1 million.

As of April 30, 2016, current assets totaled $55.2 million, compared with current liabilities of $21.7 million, a current ratio of 2.54-to-1. Cash and cash equivalents amounted to $32.4 million. Subsequent to receiving proceeds from the recent Delaware patent infringement case settlement with Life Technologies, cash and cash equivalents were over $50 million.

Segment 3Q16 Results

Enzo Clinical Labs posted its third straight quarter of double digit revenue growth, with total revenues of $18.2 million, up 16% from last year’s $15.7 million. Despite higher variable sales costs and expenses related to the expanding volume, gross margin increased 18%, to $7.0 million, from $5.9 million a year ago. Gross profit as a percentage of revenue was 38.6%, up from 37.9%. Variable expenses related to higher sales commissions and customer support resulted in SG&A increasing to $6.0 million, from $4.9 million. Nonetheless, operating income was up 6%, to $0.3 million.

With an improved order flow, Enzo Life Sciences revenues increased to $8.0 million, from $7.9 million, a year ago. Efforts to reposition the segment to achieve the Company’s growth strategies are showing positive results as revenues of higher margin products grew, while reducing those of lower margins. Life Sciences is also increasingly focused on the development and eventual production of new assays in conjunction with Clinical Labs. Thus, while revenues slowed in recent periods, in part, too, because of reduced funding in private and government oriented research, the third fiscal 2016 quarter marked a notable improvement. As a result, gross margins remained steady, at approximately $4.4 million, vs. the year ago $4.6 million, while gross profit on product sales as a percentage of revenues was essentially flat. Operating income amounted to $0.9 million, compared with $1.0 million last year.

Fiscal Nine Months Results

For the year to date, total revenues were ahead 6%, to $76.2 million, with Clinical Labs up 14% and Life Sciences off 6%. Cost of goods sold amounted to $42.7 million, $2.3 million greater than a year ago, and represented 56% of total revenues, in line with a year ago. Gross margin advanced $2 million, to $33.5 million, with gross profit as a percentage of revenues equal to 44% for both periods. R&D expenditures increased 7%, to $2.6 million, SG&A, largely reflecting increased Clinical Lab volume, was up 8%, to $32.4 million, and legal expenses declined 22%, to $5.6 million. With net legal settlements through April 2016 of $18.5 million, operating income amounted to $9.6 million, compared with a year ago loss of ($9.8) million, when legal settlements totaled $0.2 million, a $19.4 million improvement. Fully diluted per share earnings amounted to $0.20, compared with a year ago net loss per fully diluted share of ($0.24). EBITDA totaled $12.4 million, an improvement of $20.3 million from the year ago EBITDA loss of ($7.9 million).

On June 8, 2016, a wholly-owned subsidiary of Spectrum Pharmaceuticals, Inc. ("Spectrum"), Allos Therapeutics Inc. (the "Company"), and Sandoz Inc. ("Sandoz"), reported that they have entered into a settlement agreement to resolve their patent litigation relating to Folotyn (pralatrexate injection) (Filing, 8-K, Spectrum Pharmaceuticals, JUN 8, 2016, View Source [SID:1234513243]). As a result of the settlement, Sandoz will be permitted to market a generic version of Folotyn in the United States on November 15, 2022 or earlier under certain circumstances. Details of the settlement are confidential, and the parties will submit the agreement to the Federal Trade Commission and the Department of Justice. The parties will request that the court enter an order, in which it will dismiss the Company’s litigation against Sandoz. As previously reported, the Company has also settled the litigation against Teva Pharmaceuticals USA, Inc. and Dr. Reddy’s Laboratories, Ltd. & Dr. Reddy’s Laboratories, Inc. The Company’s litigation against one other generic filer continues. This litigation is described in further detail in Part II, Item 1 of Spectrum’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the U.S. Securities and Exchange Commission on May 6, 2016.

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