On March 17, 2015 Teva Pharmaceutical Industries and Ignyta reported the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5 million shares (6%) of Ignyta’s common stock (Press release, Ignyta, MAR 17, 2015, View Source [SID:1234502343]).

"We intend to use the funds to further advance our precision oncology vision by developing targeted therapies that provide meaningful benefit to specific populations of cancer patients."

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Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7 million shares at $10 per share, valuing the total offering at approximately $41.6 million.

"Teva has committed to finding novel ways for the ongoing development of early clinical stage and pre-clinical oncology R&D programs, which hold significant promise for cancer patients," said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer. "Ignyta’s capabilities and focus in oncology will give these assets the best chance of realizing their potential for patients, and of maximizing their value for Teva."

"Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "These oncology programs add critical mass to our pipeline and further enable us to leverage our precision oncology platform, including our proprietary multiplex diagnostic assays and our CLIA certified, QSR compliant diagnostic laboratory. Furthermore, these new assets complement our entrectinib development program and extend our ability to target the majority of known oncogenic drivers across multiple solid tumor indications. For example, in non-small cell lung cancer alone, we believe that our product candidates have potential activity against many of the most frequent oncogenic drivers in this disease, and we plan to explore these opportunities through innovative clinical trial designs such as master protocols."

"We are also grateful to Teva and the financial investors who share Ignyta’s precision oncology vision and invested in this latest financing," continued Dr. Lim. "We intend to use the funds to further advance our precision oncology vision by developing targeted therapies that provide meaningful benefit to specific populations of cancer patients."

Overview of Asset Acquisition Transaction

Under the terms of the asset purchase agreement with Teva, Ignyta is acquiring all of Teva’s assets and worldwide rights relating to four oncology development programs in exchange for 1.5 million shares of Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer any of these shares until March 17, 2016, and Ignyta is required to register the resale of these shares with the Securities and Exchange Commission (SEC) prior to such date.

The development programs Ignyta purchased from Teva include:

CEP-32496, which Ignyta has renamed RXDX-105, a potent small molecule inhibitor of BRAF, EGFR and RET that is currently in a Phase I/II dose escalation clinical trial;
CEP-40783, which Ignyta has renamed RXDX-106, a potent, highly selective, pseudo-irreversible inhibitor of AXL and cMET that is in late preclinical development;
CEP-40125, which Ignyta has renamed RXDX-107, a nanoformulation of a modified bendamustine with potential activity in solid tumors that is in late preclinical development; and
TEV-44229, which Ignyta has renamed RXDX-108, a potent, selective inhibitor of the atypical kinase PKCiota that is in preclinical studies. Ignyta has also acquired next generation PKCiota inhibitors in addition to the lead compound.

Ignyta also assumed all of Teva’s ongoing obligations under certain contracts relating to the purchased programs, including the agreements under which Teva in-licensed rights to the assets.

Concurrent Equity Financing

Teva has agreed to purchase 1.5 million shares of Ignyta common stock for a purchase price of $10 per share, resulting in gross proceeds to Ignyta of $15 million. Ignyta has also entered into stock purchase agreements with several additional investors that will purchase an aggregate of 2.7 million additional shares of Ignyta common stock. The offering is expected to result in aggregate gross proceeds to Ignyta of approximately $41.6 million. The offering closed concurrently with the asset purchase. Ignyta did not use a placement agent in connection with this transaction.

A shelf registration statement relating to the shares of common stock issued in the offering was filed with, and declared effective by, the SEC. A prospectus supplement relating to the offering will be filed with the SEC. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

Ignyta Slide Deck and Conference Call

Ignyta has posted a slide presentation relating to the Teva transaction, its new development programs and the concurrent equity financing on the Investors page of the company’s website at View Source On Tuesday, March 17, 2015, Ignyta will host a conference call with interested parties beginning at 5:00 p.m. ET (2:00 p.m. PT) to discuss the transactions and related matters. A live webcast of the conference call will be available online on the Investors page of the company’s website at View Source The call will also be archived and accessible at that site for one year. Alternatively, callers may participate in the conference call by dialing (888) 734-0328 (domestic) or (678) 894-3054 (international), and entering passcode 5138138.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, Ignyta’s development plans for its new product candidates, its other product candidates and discovery programs, the company’s financial status, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

On March 17, 2015 Nektar Therapeutics reported topline results from its Phase 3 BEACON study evaluating single-agent NKTR-102 in patients with advanced breast cancer (Press release, Nektar Therapeutics, MAR 17, 2015, View Source [SID:1234502307]). BEACON compared NKTR-102 to an active control arm comprised of a single chemotherapy agent of physician’s choice (TPC) in patients who were heavily pre-treated with a median of three prior therapies for metastatic disease. In a topline analysis of 852 patients from the trial, NKTR-102 provided a 2.1 month improvement in median overall survival (OS) over TPC (12.4 months for patients receiving NKTR-102 compared to 10.3 months for patients receiving TPC). Based on a stratified log-rank analysis, the primary endpoint measuring the Hazard Ratio (HR) for survival in the NKTR-102 group compared to the active control arm was 0.87 with a p-value of 0.08, which did not achieve statistical significance.

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In a pre-specified subgroup of patients with a history of brain metastases, NKTR-102 showed an improvement of 5.2 months in median OS (10.0 months compared to 4.8 months, n=67, HR 0.51, p-value < 0.01). The proportion of patients with brain metastases with 12-month survival was 44.4% in the NKTR-102 arm as compared to 19.4% in the control arm.

In a pre-specified subgroup of patients with baseline liver metastases at study entry, NKTR-102 showed an improvement of 2.6 months in median OS (10.9 months versus 8.3 months, n=456, HR 0.73, p-value < 0.002). In these patients with baseline liver metastases, the proportion of patients with 12-month survival was 46.9% in the NKTR-102 arm as compared to 33.3% in the control arm.

Breast cancer is the second leading cause of cancer related death among women, according to the National Cancer Institute. This year, an estimated 207,000 women will be diagnosed with breast cancer, and over 39,000 women will die from the disease in the U.S. Brain metastases are diagnosed in 30% of patients with advanced breast cancer.1 Liver metastases develop in approximately half of all women with metastatic breast cancer and are typically associated with advanced disease and poor outcome.2

"In BEACON, NKTR-102 provided a clinically meaningful benefit with a greater than two month survival advantage in these late-stage breast cancer patients, many who were refractory to existing therapies," said Dr. Cortes. "NKTR-102 exhibited a lower rate of high grade adverse events including a reduced rate of neutropenia as compared to active control, which dramatically decreased the need for growth factor support in the NKTR-102 arm of the study. Of particular significance, median survival in patients with brain metastases was more than double on NKTR-102 and the 12-month survival rate for this sub-group was impressive at 44% compared to 19% with other active agents."

Dr. Edith Perez, Deputy Director of the Mayo Clinic Cancer Center and Dr. Javier Cortes, Director of the Breast Cancer Program at Vall d’Hebron University Hospital in Spain, served as co-principal investigators of the global, multi-center study. BEACON enrolled 852 patients with advanced breast cancer whose disease had progressed following treatment with anthracycline, taxane and capecitabine (ATC).

"Given the frequency of cross-resistance and overlapping toxicities observed with many available agents, NKTR-102 would offer a new mechanism of action for physicians and patients in the fight against advanced breast cancer," said Dr. Joyce O’Shaughnessy, a lead BEACON investigator and steering committee member in the United States and Chair, Breast Cancer Research, The US Oncology Network and the Baylor Sammons Cancer Center, Texas Oncology, Dallas, Texas. "The results in the subgroups of patients with both liver and brain metastases are noteworthy because NKTR-102 is designed to enhance concentration of its active metabolite in highly vascular tumor environments. From a clinician’s perspective, the combination of NKTR-102’s clinical benefit and improved tolerability supports its value as a potential new treatment option in late stage breast cancer."

Secondary endpoints in the BEACON study included objective response rate (ORR) and progression-free survival (PFS), which did not achieve statistical significance in the study.

The incidence of Grade 3 and higher adverse events (AEs) was lower in the NKTR-102 arm (48%) compared to the TPC arm (63%). The most common Grade 3 and above AEs observed with NKTR-102 were diarrhea (9.6%), neutropenia (9.6%), anemia (4.7%) and fatigue (4.5%). There was no Grade 4 diarrhea reported with NKTR-102 in the trial. The most common Grade 3 and above AEs observed with TPC were neutropenia (30.8%), anemia (4.7%), and dyspnea (4.4%). Severe neuropathy (G3 or higher) was seen in 3.7% of patients on TPC versus 0.5% of patients in the NKTR-102 arm. Rates of G1/G2 alopecia in the NKTR-102 arm were also lower (10%) than in the TPC arm (23%).

"It is clear from our BEACON study that NKTR-102 has potential as an important anti-cancer agent when compared to the best available treatment options today for women with advanced breast cancer," said Howard W. Robin, president and chief executive officer of Nektar Therapeutics. "Given the significant need for new drugs to treat patients with this devastating disease, we will be exploring potential paths forward for NKTR-102 in metastatic breast cancer with regulatory agencies."

NKTR-102 was designed to be the first topoisomerase I inhibitor with a novel molecular structure that concentrates the drug in vascularized tumors and extends its circulation time in the plasma. In 2012, the FDA designated NKTR-102 as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with ATC.

Nektar will continue to review and analyze the data from the BEACON study. Data from the BEACON study will be submitted for presentation at an upcoming medical meeting.

Conference Call, Slide Presentation and Webcast Information
Nektar will host a conference call and webcast slide presentation today, March 17, 2015, at 4:45 PM Eastern Time. The call can be accessed by dialing (877) 881-2183 (U.S.) or (970) 315-0453 (international), and entering passcode 9310762. To access the live webcast, or the subsequent archived recording, visit the Investor Relations section of the Nektar website at www.nektar.com. The webcast will be available for replay on Nektar’s website through March 31, 2015.

About the BEACON Study Design
The open-label, randomized, multicenter study enrolled 852 women with locally recurrent or metastatic breast cancer who previously had been treated with ATC and had progressed following treatment. The study was conducted at 139 sites worldwide including in North America, Europe and the Republic of Korea. Nearly half of the patients enrolled in BEACON were located in North America. Patients were randomized on a 1:1 basis to receive 145 mg/m2 of single-agent NKTR-102 once every three weeks or a single agent of the physician’s choice, including ixabepilone, vinorelbine, gemcitabine, eribulin or a taxane. Randomization was stratified by geographic region, prior use of eribulin and receptor status.

The primary endpoint of the BEACON study was overall survival; key secondary endpoints included objective tumor response rates and progression-free survival. The study also evaluated specific biomarker data to assess correlation with efficacy and safety outcomes.

About NKTR-102
NKTR-102 is the first long-acting topoisomerase I inhibitor with an extended half-life and a unique structure that is designed to concentrate the drug in tumors. In patients, NKTR-102 leads to greatly prolonged plasma SN38 exposure compared with irinotecan (elimination half-life of 50 days compared with 2 days) yet peak SN38 concentrations are at least 5- to 10-times less, which may also result in a favorable tolerability profile.

About Metastatic Breast Cancer
Breast cancer is the most frequently diagnosed cancer and is the leading cause of cancer death among women worldwide.i More than 1.6 million new cases of breast cancer were diagnosed among women around the world in 2010.ii Approximately 425,000 women around the world died from the disease in 2010.iii There are approximately 200,000 new cases of breast cancer in the United States and 430,000 in Europe each year.iv Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body.

Anthracyclines and taxanes (AT) are the most active and widely used chemotherapeutic agents for breast cancer. However, the increased use of these agents at an early stage of disease often renders tumors resistant to these drugs by the time the disease recurs, thereby reducing the number of treatment options for metastatic disease. Drugs used to treat patients who progress following AT treatment can have response rates as high as 20 to 30 percent. However, resistance develops rapidly and new agents with different mechanisms of action, such as topoisomerase I inhibitors, are needed to allow novel ways to overcome the problem of drug resistance.v There are currently no FDA-approved topoisomerase I inhibitors to treat breast cancer.

On March 17, 2015 Novartis reported that the European Commission has approved Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. Jakavi is the first targeted treatment approved by the European Commission for these patients[2] (Press release, Novartis, MAR 17, 2015, View Source [SID:1234502302]).

PV is a rare and incurable blood cancer associated with an overproduction of blood cells that can cause serious cardiovascular complications, such as blood clots, stroke and heart attack[1]. Approximately 25% of patients with PV develop resistance to or intolerance of hydroxyurea and are considered to have uncontrolled disease[3]. This is typically defined as hematocrit levels greater than 45%, elevated white blood cell count and/or platelet count, and may be accompanied by debilitating symptoms and/or an enlarged spleen[3],[4],[5].

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"The European Commission’s approval of Jakavi is encouraging news for patients," said Dr. Claire Harrison, study investigator and Consultant Hematologist, Guy’s and St. Thomas’ NHS Foundation Trust, London. "Jakavi will fill an unmet need as the first treatment shown to significantly improve hematocrit, as well as symptom control and reduce spleen size in patients with polycythemia vera resistant to or intolerant of hydroxyurea."

The approval is based on data from the pivotal Phase III RESPONSE clinical trial demonstrating that a significantly greater proportion of patients achieved the composite primary endpoint of hematocrit control without use of phlebotomy and spleen size reduction, key measures of disease control, when treated with Jakavi compared to best available therapy (21% compared to 1%, respectively; p<0.0001)[1],[2]. In the study, a 50% or more improvement in PV-related symptoms was seen in 49% of Jakavi-treated patients compared to 5% of patients treated with best available therapy[2].

"The approval of Jakavi in polycythemia vera underscores what’s possible in today’s era of precision oncology research," said Bruno Strigini, President, Novartis Oncology. "Jakavi specifically targets the JAK-STAT pathway, which regulates blood cell production and is known to play a key role in the underlying mechanism of this disease, bringing patients and physicians a new way to treat polycythemia vera."

Overall, non-hematologic adverse events (AEs) were consistent with those previously seen in other Jakavi studies in PV and myelofibrosis[2],[6],[7]. Within the first 32 weeks of treatment, the most common Grade 3 or 4 hematologic AEs in the Jakavi-treatment arm were anemia (1.8%) and thrombocytopenia (5.5%)[2]. The most common non-hematologic AEs were dizziness (15.5%), constipation (8.2%) and herpes zoster (6.4%)[2]. The three most frequent non-hematological laboratory abnormalities (any Grade) were hypercholesterolemia (30.0%), raised alanine aminotransferase (22.7%) and raised aspartate aminotransferase (20.9%), which were mainly Grade 1 and 2[2].

The European Commission approval applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. Additional regulatory applications for ruxolitinib in PV are currently ongoing in countries worldwide, and further regulatory filings are under review by health authorities. Ruxolitinib, which is marketed in the US by Incyte Corporation as Jakafi, received approval in December 2014 from the US Food and Drug Administration (FDA) for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea.

About the Pivotal Clinical Trial
RESPONSE is a global, randomized, open-label trial conducted at more than 90 trial sites. 222 patients with PV resistant to or intolerant of hydroxyurea were randomized 1:1 to receive either Jakavi (starting dose of 10 mg twice daily) or best available therapy, which was defined as investigator-selected monotherapy or observation only. The Jakavi dose was adjusted as needed throughout the trial. In the Jakavi arm, patients had a PV diagnosis for a median of 8.2 years and had previously received hydroxyurea for a median of approximately three years. Most patients (>80%) had received at least two phlebotomies in the last 24 weeks prior to screening[2]. Patients were classified as intolerant or resistant to hydroxyurea based on the modified European LeukemiaNet (ELN) defined criteria[8].

The primary endpoint of the trial was the proportion of patients whose hematocrit was controlled without phlebotomy eligibility from week 8 through 32 (with no more than one phlebotomy eligibility between randomization and week 8) and whose spleen volume was reduced by 35% or more from baseline as assessed by imaging at week 32. Patients in the trial who were deemed to be eligible for phlebotomy had hematocrit that was greater than 45% and had increased three or more percentage points from the time they entered the trial (e.g., at baseline), or hematocrit greater than 48%. In addition, efficacy was further assessed using two key secondary endpoints: durable primary response and complete hematological remission. Other endpoints include safety and symptom improvement (as measured by the MPN-SAF 14-item total symptom score)[2].

About Polycythemia Vera
PV is a rare and incurable blood cancer associated with an overproduction of blood cells in the bone marrow that affects roughly one to three people per 100,000 globally[1[,[9]. The disease is driven by the dysregulation of the JAK-STAT pathway[10]. It is typically characterized by elevated hematocrit, the volume percentage of red blood cells in whole blood, which can lead to a thickening of the blood and an increased risk of blood clots, as well as an elevated white blood cell and platelet count[1]. This can cause serious cardiovascular complications, such as stroke and heart attack, resulting in increased morbidity and mortality[11]. Additionally, patients with PV may have an enlarged spleen and symptoms that are frequent and burdensome, with an overall impact on quality of life similar to that seen with myelofibrosis[5],[12].

A common PV treatment includes phlebotomy, a procedure to remove blood from the body to reduce the concentration of red blood cells, which is used to help maintain a hematocrit level below 45%[1],[11]. However, phlebotomy is usually unsuitable as a permanent treatment option due to its inability to control symptoms or effectively manage the overproduction of red blood cells, therefore cytoreductive agents, such as hydroxyurea, may be added[11]. For patients requiring phlebotomy in combination with hydroxyurea, hematocrit may fluctuate and remain at unsafe levels for significant periods of time[13]. Unfortunately, approximately 25% of PV patients become resistant to or intolerant of hydroxyurea treatment according to ELN criteria, resulting in inadequate disease control and an increased risk of progression[3].

About Jakavi
Jakavi (ruxolitinib) is an oral inhibitor of the JAK 1 and JAK 2 tyrosine kinases. Jakavi is approved by the European Commission for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea and for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post-polycythemia vera myelofibrosis or post-essential thrombocythemia myelofibrosis. Jakavi is approved in more than 80 countries for patients with myelofibrosis, including countries in the European Union, Canada, Japan and some countries in Asia, Latin and South America. Additional worldwide regulatory filings are underway in myelofibrosis and PV.

Novartis licensed ruxolitinib from Incyte Corporation for development and commercialization outside the United States. Jakavi is marketed in the United States by Incyte Corporation as Jakafi for the treatment of patients with PV who have had an inadequate response to or are intolerant of hydroxyurea and for the treatment of patients with intermediate or high-risk myelofibrosis.

The recommended starting dose of Jakavi in PV is 10 mg given orally twice daily. The recommended starting dose of Jakavi in myelofibrosis is 15 mg twice daily for patients with a platelet count between 100,000 cubic millimeters (mm3) and 200,000 mm3, and 20 mg twice daily for patients with a platelet count of >200,000 mm3. Doses may be titrated based on safety and efficacy. There is limited information to recommend a starting dose for myelofibrosis and PV patients with platelet counts between 50,000/mm3 and <100,000/mm3. The maximum recommended starting dose in these patients is 5 mg twice daily, and patients should be titrated cautiously[2].

Jakavi is a registered trademark of Novartis AG in countries outside the United States. Jakafi is a registered trademark of Incyte Corporation. The safety and efficacy profile of Jakavi has not yet been established outside the approved indication.

Jakavi Important Safety Information for Treatment of Myelofibrosis (MF) and Polycythemia Vera (PV)
Jakavi can cause serious side effects, including a decrease in blood cell count and infections. Complete blood count monitoring is recommended. Dose reduction or interruption may be required in patients with any hepatic impairment or severe renal impairment or in patients developing hematologic adverse reactions such as thrombocytopenia, anemia and neutropenia. Dose reductions are also recommended when Jakavi is co-administered with strong CYP3A4 inhibitors or fluconazole. Use of Jakavi during pregnancy is not recommended, and women should avoid becoming pregnant during Jakavi therapy. Women taking Jakavi should not breast feed. Progressive multifocal leukoencephalopathy (PML) has been reported. Physicians should be alert for neuropsychiatric symptoms suggestive of PML. Hepatitis B viral load (HBV-DNA titer) increases have been reported in patients with chronic HBV infections. Patients with chronic HBV infection should be treated and monitored according to clinical guidelines. Non-melanoma skin cancer (NMSC) has been reported in Jakavi treated patients. Periodic skin examination is recommended. Very common adverse reactions in MF (>10%) include urinary tract infections, anemia, thrombocytopenia, neutropenia, hypercholesterolemia, dizziness, headache, alanine aminotransferase increased, aspartate aminotransferase increased, bruising and weight gain. Common adverse reactions in MF (1 to 10%) include herpes zoster and flatulence. Uncommon adverse reactions in MF include tuberculosis. Very common adverse reactions in PV (>10%) include anemia, thrombocytopenia, hypercholesterolemia, hypertriglyceridemia, dizziness, alanine aminotransferase increased and aspartate aminotransferase increased. Common adverse reactions in PV (1 to 10%) include urinary tract infections, herpes zoster, weight gain, constipation and hypertension.

On March 17, 2015 Myriad reported an expansion of the Company’s collaboration with BioMarin Pharmaceutical Inc. Under the expanded collaboration, BioMarin will use Myriad’s myChoice HRD companion diagnostic test to prospectively identify patients with metastatic breast, ovarian and potentially other tumor types that may be sensitive to talazoparib(Press release, Myriad Genetics, MAR 17, 2015, View Source [SID:1234502301]). Financial terms were not disclosed.

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Talazoparib is an investigational poly-ADP ribose polymerase (PARP) inhibitor being developed by BioMarin. In the expanded relationship, the companies also will collaborate under FDA regulations and guidelines for the development and potential regulatory approval requirements for both talazoparib and myChoice HRD.

"Myriad is a pioneer in personalized medicine. Our companion diagnostics are providing clinicians with valuable biological data to accelerate and improve healthcare for their patients," said Mark Capone, president of Myriad Genetic Laboratories. "With cancer treatments, there is no one-size-fits-all approach for patients. We are excited to be working with BioMarin to help identify the patients who are most likely to benefit from talazoparib based on their own genetic makeup and biology."

The expansion adds to an ongoing collaboration that began in September 2013, when BioMarin began using Myriad’s BRACAnalysis CDx companion diagnostic test in its pivotal Phase 3 EMBRACA and Phase 2 ABRAZO clinical studies of talazoparib for advanced or metastatic breast cancer patients carrying BRCA mutations.