On January 7, 2019 Castle Biosciences, Inc., a skin cancer diagnostics company providing molecular diagnostics to improve cancer management decisions, reported a new publication demonstrating that the DecisionDx-Melanoma gene expression profile (GEP) test can identify high-risk patients who are likely to recur or die from melanoma within groups of patients often considered low risk based on traditional staging metrics (Press release, Castle Biosciences, JAN 7, 2019, View Source [SID1234532533]). Results from this multicenter study of 690 patients demonstrated that the DecisionDx-Melanoma test is an independent predictor of risk for recurrence, metastasis and melanoma-specific death. The study was published in the January 2019 issue of the Journal of the American Academy of Dermatology (JAAD).

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"In this study of a large, contemporary melanoma population, the GEP test identified patients at high risk for recurrence and death from melanoma among groups that are deemed low risk by traditional staging metrics," commented study co-author John Vetto, M.D., Professor of Surgery, Division of Surgical Oncology and Director of the Cutaneous Oncology Program at the Department of Surgery, Oregon Health & Science University. "The 31-gene GEP test provides independent information that improves risk prediction and enables physicians to develop tailored care for their patients with melanoma."

Study Details:

Patients from three previously published DecisionDx-Melanoma validation studies were combined to enable analysis of test performance in the following three clinically important subgroups that are traditionally considered low risk based on current national melanoma guidelines: (1) patients who had a negative sentinel lymph node (SLN) biopsy; (2) those with American Joint Committee on Cancer (AJCC) Stage I-IIA melanoma; and (3) those with thin (≤1 mm) tumors.

The DecisionDx-Melanoma test was performed to determine molecular class for each patient, with a Class 1A result indicating the lowest 5-year risk of metastasis and a Class 2B result indicating the highest risk. Study endpoints included recurrence-free survival (RFS; time to local, regional or distant recurrence), distant metastasis-free survival (DMFS; time to any distant metastasis) and melanoma-specific survival (MSS; time to documented death from melanoma).

In this population of 690 unique Stage I-III patients with at least 5 years of follow-up or a metastatic event, median age was 59 years and median Breslow thickness was 1.3 mm. Seventy percent of patients had Stage I or II melanoma.

Key Study Findings:

In the pooled cohort, patients with Class 1A results had significantly higher RFS, DMFS and MSS rates compared to Class 2B (p<0.0001 for all comparisons).
Seventy percent of the patients who were SLN negative and experienced metastasis were identified as Class 2 by the DecisionDx-Melanoma test. Similarly, 79% of melanoma-specific deaths among those who were SLN negative were identified as having a Class 2 result.
Patients with Stage I-IIA melanoma who received a Class 2B DecisionDx-Melanoma test result had significantly worse RFS, DMFS and MSS rates compared to patients with a Class 1A DecisionDx-Melanoma result (p<0.0001 for all comparisons).
Based on Cox multivariate analysis in the Stage I-IIA subgroup that included tumor thickness, ulceration and mitotic rate, DecisionDx-Melanoma test class was found to be the only significant predictor of all three endpoints (RFS, DMFS and MSS; p<0.05 for all).
For patients with thin tumors (≤1 mm), although most patients were low risk Class 1, 15 patients had the highest risk Class 2B result. Those patients with a Class 2B test result had a significantly reduced RFS of 64.6% compared to those with a Class 1A result (96.8%; p<0.0001).
Results of the study extend previous findings of high prognostic accuracy of the DecisionDx-Melanoma GEP test to subgroups of patients at high risk, yet for whom current national melanoma guidelines recommend low intensity follow-up and surveillance. Additionally, the study’s authors suggest that the results could have an important impact on clinical trials evaluating adjuvant treatment of Stage II disease with immunomodulatory or targeted therapies, as the identification of high-risk Stage II patients may guide appropriate patient enrollment in such trials.

The manuscript can be accessed at View Source(18)32328-4/fulltext

About DecisionDx-Melanoma

The DecisionDx-Melanoma test uses tumor biology to predict individual risk of melanoma recurrence and sentinel lymph node positivity independent of traditional factors and has been studied in over 2,900 patients. Using tissue from the primary melanoma, the test measures the expression of 31 genes. The test has been validated in three multi-center studies that have included 690 patients and have demonstrated consistent results. Performance has also been confirmed in four prospective studies including over 700 patients. The consistent high performance and accuracy demonstrated in these studies, which combined have included over 1,300 patients, provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results.

Prediction of the likelihood of sentinel lymph node positivity has also been validated in two prospective multicenter studies that included over 1,400 patients. Impact on patient management plans for one of every two patients tested has been demonstrated in multi-center and single-center studies. More information about the test and disease can be found at www.SkinMelanoma.com.

On January 7, 2019 Clovis Oncology, Inc. (NASDAQ:CLVS) reported its preliminary, unaudited revenues for the fourth quarter and full year ended December 31, 2018 (Press release, Clovis Oncology, JAN 7, 2019, View Source [SID1234532532]). The financial information presented in this news release may be adjusted as a result of completion of customary quarterly review and audit procedures.

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Unaudited preliminary results include:

$30.3-$30.8M in Rubraca product revenues for the fourth quarter of 2018 compared to $22.8M for Q3 2018 and $17.0M for Q4 2017
$95.3-$95.8M in Rubraca product revenues for the full year 2018 compared to $55.5M for FY2017
Free drug was an additional approximately 25 to 27 percent of overall commercial supply for Q4 and FY2018
$518-$521M in cash, cash equivalents and available-for-sale securities at December 31, 2018
Clovis plans to discuss these results with investors this week at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco.

"We are very pleased with our sales performance in the fourth quarter and the momentum it provides going into this year," said Patrick J. Mahaffy, CEO and President of Clovis Oncology. "Following the recent CHMP recommendation for our second ovarian cancer approval in Europe, Breakthrough Therapy Designation and a potential supplemental NDA in prostate cancer by the end of this year, as well as our successful defense last month of the rucaparib camsylate salt/polymorph patent in Europe, we feel extremely well-positioned for a strong 2019."

Clovis Oncology to Present at 37 th Annual J.P. Morgan Healthcare Conference on January 8, 2019

Clovis’ President and CEO, Patrick J. Mahaffy, will present at the 37th Annual J.P. Morgan Healthcare Conference to be held at the Westin St. Francis hotel in San Francisco on Tuesday, January 8, at 4:30 p.m. PT. A live webcast of the presentation and Q&A session can be accessed through the investor relations section of the Company’s website at clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Fourth Quarter and Full Year 2018 Financial Results Release Planned for February 26, 2019

The Company plans to report financial results for the fourth quarter and full year ended December 31, 2018, on Tuesday, February 26, 2019, after the close of the U.S. financial markets. Clovis’ senior management will host a conference call and live audio webcast at 4:30 p.m. ET to discuss the company’s results in greater detail.

About Rubraca (rucaparib)

Rubraca is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in ovarian cancer as well as several additional solid tumor indications. Studies open for enrollment or under consideration include ovarian, prostate, breast, gastroesophageal, pancreatic, lung and bladder cancers. Clovis holds worldwide rights for Rubraca.

In the United States, Rubraca is approved for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Rubraca is also approved in the United States for the treatment of adult patients with deleterious BRCA mutation (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Rubraca is an unlicensed medical product outside of the U.S. and EU.

On January 7, 2019, 2019 Mirati Therapeutics, Inc. (NASDAQ: MRTX) a clinical-stage targeted oncology company, reported a clinical collaboration with Bristol-Myers Squibb Company to evaluate the combination of sitravatinib and nivolumab (OPDIVO), in Mirati’s planned Phase 3 trial in second line non-small cell lung cancer (NSCLC) patients who have progressed following treatment with a platinum-based regimen and a checkpoint inhibitor (Press release, Mirati, JAN 7, 2019, View Source [SID1234532531]).

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The Phase 3 pivotal trial is expected to start in the first half of 2019 and will randomize patients to either the combination of sitravatinib with nivolumab or single-agent docetaxel. The trial will include an interim analysis of overall response rate (ORR) as the basis for potential accelerated approval. This interim analysis and the use of a docetaxel control arm follows guidance from Mirati’s FDA end of phase 2 meeting. The primary endpoint of the final analysis for the Phase 3 clinical trial will be overall survival.

"Our Phase 2 clinical trial of sitravatinib plus nivolumab in patients with checkpoint refractory NSCLC has shown promising activity and a well-tolerated safety profile," said Charles Baum, M.D., Ph.D., President and Chief Executive Officer of Mirati. "The trial is expected to result in a new drug application (NDA) for sitravatinib for the treatment of NSCLC patients whose tumors have progressed following treatment with a platinum containing regimen and a checkpoint inhibitor. This collaboration further validates the potential of sitravatinib and allows Mirati to invest in and expand the development of our clinical and pre-clinical programs."

Under the terms of the collaboration, Mirati will sponsor and fund the clinical trial and Bristol-Myers Squibb will provide nivolumab at no cost. Mirati maintains global development and commercial rights to sitravatinib outside of certain Asian territories, where it is partnered with BeiGene, and is free to develop the program in combination with other agents.

About Sitravatinib

Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combination with nivolumab (OPDIVO), an anti-PD-1 checkpoint inhibitor, in patients who have experienced documented disease progression following treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation.

Sitravatinib is also being evaluated as a single agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma. Sitravatinib potently inhibits these RTKs and is being investigated as a treatment option for cancer patients with CBL mutations

On January 7, 2019 Eli Lilly and Company (NYSE: LLY) and Loxo Oncology, Inc. (NASDAQ: LOXO) reported a definitive agreement for Lilly to acquire Loxo Oncology for $235.00 per share in cash, or approximately $8.0 billion (Press release, Loxo Oncology, JAN 7, 2019, View Source [SID1234532530]). Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers.

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The acquisition would be the largest and latest in a series of transactions Lilly has conducted to broaden its cancer treatment efforts with externally sourced opportunities for first-in-class and best-in-class therapies. Loxo Oncology is developing a pipeline of targeted medicines focused on cancers that are uniquely dependent on single gene abnormalities that can be detected by genomic testing. For patients with cancers that harbor these genomic alterations, a targeted medicine could have the potential to treat the cancer with dramatic effect.

Loxo Oncology has a promising portfolio of approved and investigational medicines, including:

LOXO-292, a first-in-class oral RET inhibitor that has been granted Breakthrough Therapy designation by the FDA for three indications, with an initial potential launch in 2020. LOXO-292 targets cancers with alterations to the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types, including certain lung and thyroid cancers as well as a subset of other cancers.
LOXO-305, an oral BTK inhibitor currently in Phase 1/2. LOXO-305 targets cancers with alterations to the Bruton’s tyrosine kinase (BTK), and is designed to address acquired resistance to currently available BTK inhibitors. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas.
Vitrakvi, a first-in-class oral TRK inhibitor developed and commercialized in collaboration with Bayer that was recently approved by the U.S. Food and Drug Administration (FDA). Vitrakvi is the first treatment that targets a specific genetic abnormality to receive a tumor-agnostic indication at the time of initial FDA approval.
LOXO-195, a follow-on TRK inhibitor also being studied by Loxo Oncology and Bayer for acquired resistance to TRK inhibition, with a potential launch in 2022.
"Using tailored medicines to target key tumor dependencies offers an increasingly robust approach to cancer treatment," said Daniel Skovronsky, M.D., Ph.D., Lilly’s chief scientific officer and president of Lilly Research Laboratories. "Loxo Oncology’s portfolio of RET, BTK and TRK inhibitors targeted specifically to patients with mutations or fusions in these genes, in combination with advanced diagnostics that allow us to know exactly which patients may benefit, creates new opportunities to improve the lives of people with advanced cancer."

"We are gratified that Lilly has recognized our contributions to the field of precision medicine and are excited to see our pipeline benefit from the resources and global reach of the Lilly organization," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "Tumor genomic profiling is becoming standard-of-care, and it will be critical to continue innovating against new targets, while anticipating mechanisms of resistance to available therapies, so that patients with advanced cancer have the chance to live longer and better lives."

"Lilly Oncology is committed to developing innovative, breakthrough medicines that will make a meaningful difference for people with cancer and help them live longer, healthier lives," said Anne White, president of Lilly Oncology. "The acquisition of Loxo Oncology represents an exciting and immediate opportunity to expand the breadth of our portfolio into precision medicines and target cancers that are caused by specific gene abnormalities. The ability to target tumor dependencies in these populations is a key part of our Lilly Oncology strategy. We look forward to continuing to advance the pioneering scientific innovation begun by Loxo Oncology."

"We are excited to have reached this agreement with a team that shares our commitment to ensuring that emerging translational science reaches patients in need," said Jacob Van Naarden, chief operating officer of Loxo Oncology. "We are confident that the work we have started, which includes an FDA approved drug, and a pipeline spanning from Phase 2 to discovery, will continue to thrive in Lilly’s hands."

Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Loxo Oncology for a purchase price of $235.00 per share in cash, or approximately $8.0 billion. The transaction is not subject to any financing condition and is expected to close by the end of the first quarter of 2019, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Loxo Oncology’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Loxo Oncology that are not tendered into the tender offer through a second-step merger at the tender offer price.

The tender offer represents a premium of approximately 68 percent to Loxo Oncology’s closing stock price on January 4, 2019, the last trading day before the announcement of the transaction. Loxo Oncology’s board recommends that Loxo Oncology’s shareholders tender their shares in the tender offer. Additionally, a Loxo Oncology shareholder, beneficially owning approximately 6.6 percent of Loxo Oncology’s outstanding common stock, has agreed to tender its shares in the tender offer.

This transaction will be reflected in Lilly’s financial results and financial guidance according to Generally Accepted Accounting Principles (GAAP). Lilly will provide an update to its 2019 financial guidance, including the expected impact from the acquisition of Loxo Oncology, as part of its fourth-quarter and full-year 2018 financial results announcement on February 13, 2019.

For Lilly, Deutsche Bank is acting as the exclusive financial advisor and Weil, Gotshal & Manges LLP is acting as legal advisor in this transaction. For Loxo Oncology, Goldman Sachs & Co. LLC is acting as exclusive financial advisor and Fenwick & West LLP is acting as legal advisor.

Conference Call and Webcast
Lilly will conduct a conference call with the investment community and media today at 8:45 a.m. EST to discuss the acquisition of Loxo Oncology. Investors, media and the general public can access a live webcast of the conference call through the Webcasts & Presentations link that will be posted on Lilly’s website at www.lilly.com. The webcast of the conference call will be available for replay through February 7, 2019.

About LOXO-292
LOXO-292 is an oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 has been granted Breakthrough Therapy Designation by the U.S. FDA for three indications, and could launch as early as 2020.

About LOXO-305
LOXO-305 is an investigational, highly selective non-covalent Bruton’s tyrosine kinase (BTK) inhibitor. BTK plays a key role in the B-cell antigen receptor signaling pathway, which is required for the development, activation and survival of normal white blood cells, known as B-cells, and malignant B-cells. BTK is a validated molecular target found across numerous B-cell leukemias and lymphomas including chronic lymphocytic leukemia, Waldenstrom’s macroglobulinemia, mantle cell lymphoma and marginal zone lymphoma.

About Vitrakvi (larotrectinib)
Vitrakvi is an oral TRK inhibitor for the treatment of adult and pediatric patients with solid tumors with a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation that are either metastatic or where surgical resection will likely result in severe morbidity, and have no satisfactory alternative treatments or have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

About LOXO-195
LOXO-195 is a selective TRK inhibitor that is being investigated to address potential mechanisms of acquired resistance that may emerge in patients receiving Vitrakvi (larotrectinib) or other multikinase inhibitors with anti-TRK activity.

On January 7, 2019 Diplomat Pharmacy, Inc. (NYSE: DPLO), is reported its 2018 financial guidance and providing a preliminary 2019 outlook in connection with its presentation today at the JP Morgan Healthcare Conference in San Francisco (Press release, Diplomat Speciality Pharmacy, JAN 7, 2019, View Source [SID1234532529]).

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Diplomat now expects 2018 revenue to be at the lower end of the previously communicated $5.5 to $5.7 billion range and adjusted EBITDA to be at the higher end of the previously communicated $164 to $170 million range.

2018 revenue is expected to be within the range of $5.5 billion and $5.6 billion.
2018 adjusted EBITDA is now expected to be within the range of $167 million and $170 million, an increase of at least 64% based on the low end of the 2018 range vs. 2017.
Diluted GAAP EPS 2018 is expected to range from ($0.08) to $0.00.
Net debt, including contingent consideration at December 31, 2018 is expected to be approximately $630 million.
The company also announced that Joel Saban, president of Diplomat, and Albert Thigpen, president and chief operating officer of CastiaRx, are leaving the company effective immediately. The company has initiated searches for their replacements. Chairman and CEO Brian Griffin will directly oversee CastiaRx and the operational review of that business pending completion of the search.

Griffin commented, "Diplomat delivered strong revenue and EBITDA growth in 2018 despite challenges in our CastiaRx PBM segment. Solid specialty growth, robust infusion performance, and better than expected synergy capture following completion of the PBM integration drove 2018 results, and investments we have made in sales, systems, processes and facilities are expected to drive future growth and profitability, positioning the company well for 2019 and beyond."

Griffin noted that Diplomat has been selected by Hospitality Rx as the exclusive provider of specialty pharmacy services for its UNITE HERE HEALTH (UHH) plan members. UHH is a multiemployer union plan that provides health benefits to approximately 250,000 members across the nation.

In addition, Diplomat announced a partnership today with CSI Specialty Group, a globally recognized specialty pharmacy consulting firm. Diplomat will provide limited-distribution drugs and specialty care management solutions to health system clients.

"These recent contract awards are evidence that the payer sales strategy launched in early 2018 is gaining traction," said Griffin. "Payers are increasingly interested in Diplomat’s specialty and infusion services on a carve-out basis as they focus on improved patient care and driving down total healthcare costs. We continue to see interest and are in discussions with mid and large-tier health plans looking to enhance the management of not only their specialty pharmacy benefit, but also their specialty medical drug benefit. We expect to announce additional awards in the coming months as we leverage coordinated sales and clinical efforts across specialty and infusion."

Preliminary 2019 Outlook

In 2019, Diplomat expects:

Revenue in the range of $5.6 billion to $5.8 billion, representing an approximate 3 percent year-over-year increase based on the midpoints of 2018 and 2019 guidance ranges.
Flat to low-single-digit percent year-over-year adjusted EBITDA growth compared to the mid-point of updated 2018 guidance.
Achievement of net debt/EBITDA below 3.0x by the end of 2019.
Griffin commented, "We expect 2019 to be characterized by continued growth in specialty and infusion given our payer-focused strategy, and actions we are taking to return our PBM business to growth." In 2019, Diplomat also expects:

Continued sales growth in specialty pharmacy, supported by further penetration in the payer space, particularly with health plans, as the company leverages coordinated sales and clinical efforts across specialty and infusion.
Specialty infusion growth should also benefit from growth in key therapeutic areas, additional sales resources added in 2018, further traction from biosimilars, and new limited-distribution drugs, with the potential to expand therapeutic areas and geographically via tuck-in acquisitions.
A realignment of the PBM to increase win rates and offset lost business. The company expects to significantly expand experienced sales and account management resources to drive business wins and position the business to return to growth in 2020.
The preliminary 2019 outlook assumes a revenue contribution from CastiaRx of $450 million to $500 million. The revenue range expected to be generated by CastiaRx includes approximately $200 million in previously disclosed Medicare Part D contract losses, an additional $120 million combined revenue impact from client losses impacting 2019 and the pricing impact of contract renewals, $35 million in January 1, 2019 new business, as well as further awards given a strong pipeline for the remainder of 2019.

Management Changes and CastiaRx Review

"While we’ve been seeing some positive signs for the CastiaRx brand and value proposition, there is no question that this segment disappointed in 2018," said Griffin. "We are looking at this business very closely and are taking decisive steps to address its challenges, including key senior management changes. We have also engaged an external consultant with deep PBM operational experience to help implement operational performance improvement initiatives. We expect this review to be completed over the next several weeks and expect to provide an update on the review as part of our Q4 earnings call."

Commenting on the departures of Saban and Thigpen, "They have contributed much to Diplomat during their tenure and we wish them the best for the future."

"2019 will be a critical year for CastiaRx to demonstrate positive momentum and I will be personally leading the CastiaRx business on an interim basis, while we evaluate options for permanent leadership. We are focused on finding the right talent to maximize value for patients, payers and shareholders," concluded Griffin.

Presentation Information

As previously announced, Brian Griffin, Chairman and CEO, and Atul Kavthekar, CFO of Diplomat Pharmacy, Inc., are scheduled to present at the 37th Annual J.P. Morgan Healthcare conference on Monday, Jan. 7, 2019, at 8:00 a.m. PT. The related presentation materials are available on the investor relations section of Diplomat’s website at ir.diplomat.is. A live audio webcast of the presentation will also be available on the investor relations section of Diplomat’s website at ir.diplomat.is. An archived audio recording and related presentation materials will be online for 90 days at the same URL.