On August 4, 2015 Pfizer Inc. (NYSE: PFE) reported that the European Commission (EC) has approved under the European Union (EU) Merger Regulation the company’s pending acquisition of Hospira, Inc. (NYSE: HSP) (Press release, Pfizer, AUG 4, 2015, View Source [SID:1234506997]). The Commission’s decision includes Pfizer’s commitment to divest certain assets.

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"We are pleased to have achieved a significant milestone for Pfizer’s pending acquisition of Hospira with the EC’s approval of the transaction," said Ian Read, chairman and chief executive officer, Pfizer. "We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close in the second half of 2015."

Completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, governmental and regulatory approvals in certain other jurisdictions and other usual and customary closing conditions.

On August 4, 2015 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported that it has entered into an exclusive worldwide licensing agreement with Johns Hopkins University for [18F]DCFPyL ("PyL"), a clinical-stage prostate specific membrane antigen (PSMA)-targeted imaging agent for prostate cancer (Press release, Progenics Pharmaceuticals, AUG 4, 2015, View Source [SID:1234506994]). PyL, when used in conjunction with high-resolution PET imaging, has shown potential for use in identifying prostate cancer and sites of relapse. Financial terms of the transaction were not disclosed.

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PyL was developed by a team led by Martin G. Pomper, M.D., Ph.D. at the Johns Hopkins University School of Medicine. An early stage clinical trial of PyL with PET imaging in men with prostate cancer demonstrated uptake of PyL in sites of putative metastatic disease and primary tumors not seen with currently approved imaging techniques, suggesting the potential for high sensitivity and specificity in detecting prostate cancer.

"PSMA-targeted imaging agents have the potential to change how prostate cancer is diagnosed, monitored and treated and have the potential to lead to better outcomes for patients," said Mark Baker, CEO. "Based on studies conducted by Dr. Pomper’s team, PyL, a PET imaging agent, has demonstrated the potential to detect even minimal levels of prostate cancer which will complement our SPECT/CT imaging agent 1404, currently in development. We are excited about the opportunity to advance the development of PyL."

PyL complements Progenics’ existing portfolio of candidates for the detection and treatment of prostate cancer, including 1404, the Company’s lead PSMA-targeted imaging agent that is used in conjunction with widely-available SPECT-CT imaging. Progenics intends to initiate a Phase 3 program for 1404 for initial diagnosis and early monitoring applications, while initially focusing the development of PyL with high resolution PET imaging to detect and localize recurrent disease in patients who have experienced a biochemical relapse.

About PyL for PET Imaging of Prostate Cancer

PyL (also known as [18F]DCFPyL) is a clinical-stage, fluorinated PSMA-targeted PET imaging agent for prostate cancer that was discovered and developed at the Center for Translational Molecular Imaging at the Johns Hopkins University School of Medicine. A proof-of-concept study published in the April 2015 issue of the Journal of Molecular Imaging and Biology demonstrated that PET imaging with PyL showed high levels of PyL uptake in sites of putative metastatic disease and primary tumors, suggesting the potential for high sensitivity and specificity in detecting prostate cancer.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics’ molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.

On August 04, 2015 Momenta Pharmaceuticals, Inc. (Nasdaq:MNTA) today reported its financial results for the second quarter ended June 30, 2015 (Press release, Momenta Pharmaceuticals, AUG 4, 2015, View Source [SID:1234506993]).

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For the second quarter of 2015, the Company reported total revenues of $44.9 million, consisting primarily of product and milestone revenues relating to the approval and launch of GlatopaTM (glatiramer acetate injection). Momenta reported a net loss of $(2.2) million, or $(0.04) per share for the second quarter compared to a net loss of $(26.2) million, or $(0.51) per share for the same period in 2014. At June 30, 2015, the Company had cash, cash equivalents, and marketable securities of $377.2 million.

"Momenta reached a significant milestone in the second quarter of 2015 with the launch of Glatopa, our second approved complex generic product and the first and only generic version of daily COPAXONE available on the market. We are pleased with Sandoz’s execution of the Glatopa launch and encouraged by the strong initial uptake seen thus far," said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. "In the second quarter, we also strengthened our balance sheet through a successful equity financing laying the groundwork for the growth and advancement of our biosimilars and novel drug pipelines."

Second Quarter Highlights and Recent Events

Complex Generics:

GlatopaTM, generic version of daily COPAXONE 20 mg (glatiramer acetate injection)

On April 16, 2015, Glatopa was approved by the FDA as the first and only "AP-rated," substitutable generic version of daily COPAXONE 20 mg.

On June 18, 2015, the U.S. Court of Appeals for the Federal Circuit (CAFC) again found the remaining patent on daily COPAXONE 20 mg at issue in Teva’s infringement suit to be invalid.

Sandoz launched Glatopa on June 18, 2015. In the second quarter of 2015, Momenta recorded $19.2 million in product revenues from Glatopa sales, net of a deduction of $9.0 million for reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses.

Under its collaboration agreement with Sandoz, Momenta earned a $10.0 million milestone payment upon Glatopa receiving sole FDA approval and an additional $10.0 million milestone payment upon first commercial sale of Glatopa.
The ANDA for a three-times-a-week generic COPAXONE 40 mg (glatiramer acetate injection), submitted by Sandoz in August 2014, is under FDA review.

Enoxaparin Sodium Injection

In June 2015, the Company and Sandoz amended their enoxaparin collaboration agreement replacing the royalty payment with a 50% profit share. The amendment was effective April 1, 2015. In the second quarter of 2015, Momenta earned $0.1 million in product revenues from enoxaparin sales.

The Company continues to pursue the patent infringement case related to Momenta’s U.S. Pat. 7,575,886 against Amphastar and Teva. In a 2012 decision, the CAFC vacated a preliminary injunction based on the Hatch Waxman "safe harbor" (Momenta Pharmaceuticals vs. Amphastar Pharmaceuticals, Inc. Fed. Cir. Aug. 3, 2012). On May 4, 2015, the CAFC held a hearing on the Company’s appeal of summary judgment, and requested the views of the U.S. Solicitor General on the government’s interpretation of the safe harbor provision. On July 13, 2015, the U.S. Solicitor General filed its brief providing support of Momenta’s interpretation of the "safe harbor". A CAFC decision is expected in 2015.

Biosimilars:

M923, a biosimilar version of HUMIRA (adalimumab), is currently being studied in a randomized, double-blind, single-dose study in healthy volunteers to compare its pharmacokinetics, safety, tolerability and immunogenicity versus HUMIRA. Momenta and Baxalta (formerly Baxter) expect to have data from this study in the fourth quarter of 2015. The target date for the first regulatory submission for approval is 2017.

Momenta continues to develop M834, a biosimilar version of ORENCIA (abatacept), and its portfolio of other biosimilar candidates and is in active discussions with potential collaboration partners to assist in their development and commercialization.
On July 2, 2015, Momenta filed a petition for Inter Partes Review (IPR) with the Patent Trial and Appeal Board to challenge the validity of Bristol Myers Squibb’s ORENCIA subcutaneous formulation U.S. Pat. 8,476,239. The Company expects a decision on institution of the IPR in January 2016.

Novel Drug:

Necuparanib (novel oncology candidate)

Momenta’s Phase 2 trial to evaluate the antitumor activity of necuparanib in combination with Abraxane (nab-paclitaxel) plus gemcitabine, versus Abraxane plus gemcitabine alone, is currently enrolling. The Company expects to have clinical data available in the first half of 2017.
Momenta presented updated data from its Phase 1 study evaluating necuparanib in combination with Abraxane and gemcitabine in patients with metastatic pancreatic cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting on June 1, 2015. Necuparanib showed acceptable safety, tolerability, and encouraging signals of activity in the updated Phase 1 dataset.

Autoimmune Drugs

Momenta’s three novel autoimmune candidates are in preclinical development. These candidates include a hyper-sialylated IVIg (hsIVIg), a high potency alternative to IVIg, and two recombinant molecules: M230, a Selective Immunomodulator of Fc receptors (SIF3) and M281, an anti-FcRn monoclonal antibody. The Company is advancing the recombinant candidates with a goal of entering the clinic in late 2016, and is continuing its efforts to identify and explore potential partnering opportunities for the further development and commercialization of its hsIVIg program.

Second Quarter 2015 Financial Results

Total revenues for the second quarter of 2015 were $44.9 million compared to $11.0 million for the same period in 2014. Total revenues for the second quarter of 2015 include $19.2 million in product revenue, which represents 50% of contractual profit earned from net sales of Glatopa by Sandoz, net of a deduction of $9.0 million in reimbursement to Sandoz of the Company’s share of pre-launch Glatopa-related legal expenses.

Enoxaparin product revenue for the second quarter of 2015 was $0.1 million compared to $5.7 million in the same period in 2014. The decrease in enoxaparin product revenue was primarily due to the amendment of the enoxaparin sodium injection collaboration agreement in June 2015 which replaced Sandoz’ obligation to pay the Company a royalty on net sales with an obligation to pay 50% of profit on sales. The amendment became effective for the second quarter of 2015.

Collaborative research and development revenue for the second quarter of 2015 was $25.6 million, compared to the $5.3 million recorded in the same quarter last year. In the second quarter of 2015 the Company earned $20.0 million in milestone payments under the Sandoz collaboration upon receiving sole FDA approval and upon first commercial sale of Glatopa.

Research and development expenses for the second quarter of 2015 were $34.0 million, compared to $26.1 million for the same period in 2014. The increase of $7.9 million, or 30%, from the 2014 period primarily resulted from increases of: $2.2 million in third-party process development costs for the biosimilars programs; $2.0 million in preclinical and manufacturing expenditures to advance the novel autoimmune programs; $1.6 million in clinical trial expenses as the necuparanib Phase 2 clinical trial continued to enroll patients; and $1.4 million in share-based compensation expense associated with performance-based stock awards.

General and administrative expenses for the quarter ended June 30, 2015, were $13.3 million, compared with $11.2 million for the same period in 2014. The increase of $2.1 million, or 19%, from the 2014 was primarily due to an increase of $1.5 million in share-based compensation expenses associated with performance based stock awards.

At June 30, 2015, Momenta had $377.2 million in cash, cash equivalents and marketable securities. This cash position excludes restricted cash of $20.7 million, of which $17.5 million is reserved as collateral for a security bond related to enoxaparin legal proceedings, and $3.2 million for letters of credit related to the company’s two leased facilities.

In May 2015, the Company sold an aggregate of 8,337,500 shares of common stock through an underwritten public offering at a price to the public of $19.00 per share. Momenta received net proceeds of $148.4 million, after deducting underwriting discounts and commissions and customary offering expenses.

In April 2015, the Company concluded sales of its common stock under its May 2014 "At the Market" (ATM) Equity Offering Sales Agreement with Stifel, Nicolaus & Company. In the second quarter of 2015, the Company recorded net proceeds of $21.5 million from the sale of 1.4 million shares of common stock sold through the ATM.

Also in April 2015, Momenta entered into a second ATM agreement with Stifel under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $75 million. In the second quarter of 2015, the Company recorded net proceeds of $9.3 million from the sale of 0.5 million shares of common stock sold through the 2015 ATM.

Financial Guidance

Today, Momenta provided guidance that it expects its operating expenses, excluding stock-based compensation and net of collaborative revenues, to be approximately $36 – $40 million per quarter for the second half of 2015.

On August 4, 2015 Incyte Corporation (Nasdaq: INCY) today reported 2015 second-quarter financial results, including revenue from Jakafi (Press release, Incyte, AUG 4, 2015, View Source;p=RssLanding&cat=news&id=2075248 [SID:1234506992]).

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The Company highlighted the continued momentum in the commercialization of Jakafi in the U.S., as well as progress being made across its clinical portfolio, including the results of two pivotal trials of baricitinib that were presented with Eli Lilly and Company ("Lilly") at the 2015 European League Against Rheumatism (EULAR) meeting in June. In addition, positive proof-of-concept results from the novel:novel combination of Incyte’s PI3Kδ inhibitor INCB40093 and JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at both the 2015 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and European Hematology Association (EHA) (Free EHA Whitepaper) annual meetings in the second quarter of 2015.

"The commercial performance of Jakafi in Q2 2015 was very strong, confirming both underlying growth from the myelofibrosis indication and an acceleration in Jakafi growth from the launch in patients with uncontrolled polycythemia vera," stated Hervé Hoppenot, Incyte’s President and Chief Executive Officer. "Recent data presented from our product candidates, and the progress we are making in recruiting multiple clinical trials, further illustrate the strength and diversity of our development portfolio."

Jakafi is approved by the U.S. Food and Drug Administration for treatment of people with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post–polycythemia vera MF, and post–essential thrombocythemia MF.

2015 Second-Quarter Financial Results

Revenues For the quarter ended June 30, 2015, net product revenues of Jakafi were $142 million as compared to $84 million for the same period in 2014, representing 69 percent growth. For the six months ended June 30, 2015, net product revenues of Jakafi were $258 million as compared to $154 million for the same period in 2014, representing 68 percent growth. For the quarter and six months ended June 30, 2015, product royalties from sales of Jakavi (ruxolitinib) outside of the United States received from Novartis, the Company’s collaborator, were $17 million and $33 million, respectively, as compared to $12 million and $22 million, respectively, for the same periods in 2014. For the quarter ended June 30, 2015, contract revenues were $3 million as compared to $3 million for the same period in 2014. For the six months ended June 30, 2015, contract revenues were $31 million as compared to $13 million for the same period in 2014. The $18 million increase in contract revenues for the six months ended June 30, 2015 compared to the same period in 2014 relates to an increase in milestone payments earned from Novartis. For the quarter ended June 30, 2015, total revenues were $163 million as compared to $100 million for the same period in 2014. For the six months ended June 30, 2015, total revenues were $322 million as compared to $189 million for the same period in 2014.

Research and development expenses Research and development expenses for the quarter and six months ended June 30, 2015 were $112 million and $231 million, respectively, as compared to $85 million and $160 million, respectively, for the same periods in 2014. Included in research and development expenses for the quarter and six months ended June 30, 2015 were non-cash expenses related to equity awards to our employees of $10 million and $20 million respectively. The increase in research and development expenses was primarily due to the expansion of the Company’s clinical portfolio. Also included in research and development expenses for the six months ended June 30, 2015 was the one-time upfront payment to Agenus related to our license, development and commercialization agreement.

Selling, general and administrative expenses Selling, general and administrative expenses for the quarter and six months ended June 30, 2015 were $52 million and $97 million, respectively, as compared to $41 million and $78 million, respectively, for the same periods in 2014. Included in selling, general and administrative expenses for the quarter and six months ended June 30, 2015 were non-cash expenses related to equity awards to our employees of $7 million and $15 million respectively. Increased selling, general and administrative expenses reflected additional costs related to the commercialization of Jakafi.

Unrealized gain on long term investment Unrealized gain on long term investment of $27 million for the quarter and six months ended June 30, 2015 represents the fair market value adjustment of the Company’s investment in Agenus.

Net income / (loss) Net income for the quarter ended June 30, 2015 was $9 million, or $0.05 per basic and diluted share, as compared to a net loss of $37 million, or $0.22 per basic and diluted share, for the same period in 2014. Net loss for the six months ended June 30, 2015 was $9 million, or $0.05 per basic and diluted share as compared to a net loss of $71 million, or $0.43 per basic and diluted share, for the same period in 2014.

Cash, cash equivalents and marketable securities position As of June 30, 2015, cash, cash equivalents and marketable securities totaled $627 million, as compared to $600 million as of December 31, 2014.

2015 Financial Guidance

Product Update

Jakafi (ruxolitinib) – JAK1 and JAK2 Inhibitor

Follow-up results from the pivotal RESPONSE trial of ruxolitinib in patients with uncontrolled polycythemia vera were presented at the 2015 ASCO (Free ASCO Whitepaper) meeting, showing 83% of patients were still receiving ruxolitinib at a median exposure of 111 weeks.

The pivotal Phase III JANUS 1 and JANUS 2 studies of ruxolitinib in second line metastatic pancreatic cancer are ongoing. Three Phase II trials of ruxolitinib are ongoing in colorectal, breast and non-small cell lung cancer (NSCLC) patients.

baricitinib – JAK1 and JAK2 Inhibitor

In June 2015, the Company and Lilly presented five abstracts for baricitinib, including oral presentations of data from the pivotal RA-BEACON and RA-BUILD studies, at the 2015 EULAR meeting. The Company and Lilly expect to share results of two further Phase III studies in various disclosures in late 2015.

In April 2015, positive proof-of-concept data for baricitinib for the treatment of patients with diabetic nephropathy (diabetic kidney disease) were presented by Lilly at the scientific sessions of the American Diabetes Association.

epacadostat (INCB24360) – IDO1 Inhibitor

Four clinical trials to evaluate epacadostat in combination with immune checkpoint inhibitors are all recruiting patients. These trials are evaluating epacadostat in combination with Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab), AstraZeneca/MedImmune’s investigational PD-L1 inhibitor, MEDI4736, Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo (nivolumab), and Roche/Genentech’s investigational PD-L1 inhibitor, MPDL3280A.

INCB39110 & INCB52793 – JAK1-Selective Inhibitors

In May 2015, initial results of the combination of INCB39110 plus INCB40093, Incyte’s PI3Kδ inhibitor, in patients with B-cell malignancies were presented at the 2015 ASCO (Free ASCO Whitepaper) meeting. INCB39110 is also in a Phase II trial in NSCLC patients, in combination with erlotinib, and in a Phase II trial, in combination with gemcitabine and nab-paclitaxel, in patients with pancreatic cancer.

The Company’s second JAK1-selective inhibitor, INCB52793, is in a Phase I/II monotherapy dose-escalation trial in advanced malignancies.

INCB40093 & INCB50465 – PI3Kδ Inhibitors

Initial results of the combination of INCB40093 and the JAK1-selective inhibitor INCB39110 in B-cell malignancies were presented at the 2015 ASCO (Free ASCO Whitepaper) meeting.

INCB50465 is a highly-potent PI3Kδ inhibitor, and an open-label, dose-escalation study of INCB50465 in subjects with previously treated B-cell malignancies has been initiated.

capmatinib (INC280) – c-MET Inhibitor

Capmatinib is being investigated by Novartis in a variety of solid tumors, including advanced c-MET positive hepatocellular carcinoma and c-MET positive/EGFR-TKI-resistant NSCLC, as well as in combination, including with Bristol-Myers Squibb’s PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), in a Phase II trial of patients with NSCLC.

INCB54828 – FGFR Inhibitor

INCB54828 is in an open-label, dose-escalation study in subjects with advanced malignancies.

INCB54329 – BRD Inhibitor

In the second quarter of 2015, the Company initiated an open-label, dose-escalation study of INCB54329 in subjects with advanced malignancies.

On August 4, 2015 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that two abstracts summarizing data from studies in Europe and the U.K. of treatment with the Delcath Hepatic CHEMOSAT Delivery System (CHEMOSAT) will be presented at the upcoming European Association of Dermato Oncology (EADO) annual congress, which will be held in Marseille, France, October 28-31, 2015 (Press release, Delcath Systems, AUG 4, 2015, View Source;p=RssLanding&cat=news&id=2075366 [SID:1234506991]).

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The abstracts are:

Treating Unresectable Liver Metastases Of Uveal Melanoma With Percutaneous Hepatic Perfusion With Melphalan, a study conducted at Leiden University Medical Center in the Netherlands.
Liver Directed Treatment Of Metastatic Uveal Melanoma By Chemosaturation Via Percutaneous Hepatic Perfusion – A Single Centre Experience, a study conducted at Southampton University in the United Kingdom.