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Xtandi Prospers, One Down, One To Go For AMAG, There's Reason For CORT's Fall

Today's Daily Dose brings you news about commercial launch of leukemia drug VIDAZA in China; promising results of adding XTANDI to androgen deprivation therapy in non-metastatic Castration-Resistant Prostate Cancer; encouraging data from Calithera's early trials of CB-839 in renal cell carcinoma; positive results from Roche's IMmotion151 trial; potential generic competition to Corcept's Cushing's syndrome drug and expanded FDA approval for Amag Pharma's iron replacement therapy.

Read on...

The FDA has approved AMAG Pharmaceuticals Inc.'s (AMAG) supplemental New Drug Application to expand Feraheme's use in all eligible adult patients with iron deficiency anemia who have failed or cannot tolerate oral iron treatment.

Feraheme, an iron replacement therapy, given by injection, is already approved for the treatment of iron deficiency anemia in adult patients only with chronic kidney disease.

The expanded Feraheme label will double the addressable market opportunity estimated to be nearly a million patients per year for the iron replacement therapy, according to the Company.

According to IMS data, the current addressable IV iron market is valued at $390 million. Feraheme notched up revenue of $26.1 million in Q3, 2017, compared to $22.3 million in Q3, 2016.

Another regulatory catalyst to watch out for is the FDA decision on Makena, the only FDA-approved therapy to reduce recurrent preterm birth in certain at-risk women.
Makena is currently available as intramuscular injection formulation. The Company has sought FDA approval for the subcutaneous auto-injector form of the drug, and the FDA decision is expected on February 14, 2018.

AMAG closed Monday's trading at $13.25, down 7.34%.

Astellas Pharma Inc. and Pfizer Inc.'s (PFE) phase III trial evaluating XTANDI plus androgen deprivation therapy (ADT) versus ADT alone in patients with non-metastatic Castration-Resistant Prostate Cancer has demonstrated that adding XTANDI to standard of care ADT significantly reduced the risk of metastasis or death by 71%.

In the trial, dubbed PROSPER, the metastasis-free survival was 36.6 months for men who received XTANDI compared to 14.7 months with ADT alone. The companies reported positive top line results from the PROSPER study last September.

XTANDI is already approved for the treatment of patients with metastatic castration-resistant prostate cancer.

Maha Hussain of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University noted that there are currently no approved systemic therapies for patients with non-metastatic CRPC in the U.S.

PFE closed Monday's trading at $34.67, down 5.30%.

BeiGene Ltd. (BGNE) has commercially launched VIDAZA (azacitidine for injection) in China.

VIDAZA is approved in China for patients with Intermediate-2 / High-risk myelodysplastic syndrome (MDS), acute myeloid leukemia (AML) with 20-30% bone marrow blasts and chronic myelomonocyte leukemia (CMML).

BeiGene gained an exclusive license to commercialize Celgene's approved therapies in China - ABRAXANE, REVLIMID and VIDAZA, under an agreement entered into by the two companies last July.

BGNE closed Monday's trading at $130.62, down 4.58%. In after-hours, the stock was up 2.67% to $134.10.

Calithera Biosciences Inc.'s (CALA) phase I study of CB-839 in combination with Exelixis Inc's (EXEL) approved drug Cabometyx in patients with renal cell carcinoma has demonstrated a 40% overall response rate and 100% disease control.

Based on the promising clinical results, the Company is planning to initiate a global, randomized phase II trial of CB-839 in combination with Cabometyx, dubbed CANTATA, in the second quarter of 2018.

The Company also presented updated results from a phase I study of CB-839 in combination with Novartis' blockbuster cancer drug Afinitor in renal cell carcinoma patients.

According to the updated data, 92% of patients experienced control of their disease, including one patient with a partial response and 21 patients with stable disease, and the median progression free survival was 5.8 months.

A phase II study of CB-839 in combination with Afinitor, dubbed ENTRATA, is underway, and the trial, which been modified to enroll approximately 65 patients, is currently enrolling patients.

CALA closed Monday's trading at $7.00, down 4.76%.

Shares of Corcept Therapeutics Inc. (CORT) plunged more than 26% on Monday, following Teva Pharmaceuticals' (TEVA) submission of an Abbreviated New Drug Application to the FDA seeking approval for a generic version of Korlym in the United States.

Korlym is Corcept's only marketed drug, and it is indicated for the control of hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance.

Teva, in its ANDA, has stated that its generic version of Korlym will not infringe the patents, one which expires in August 2028, and another, which expires in August 2036.

Korlym generated revenue of $81.3 million in 2016, and is expected to bring home revenue of $159.2 million in 2017 for Corcept.

CORT closed Monday's trading at $17.26, down 26.43%.

Eyegate Pharmaceuticals Inc. (EYEG) slumped nearly 42% on Monday, following disappointing results from a phase 2b study of EGP-437 combination product for pain and inflammation in patients having undergone cataract surgery.

Although, EGP-437 demonstrated a higher rate of success compared to vehicle at all time points, the co-primary endpoints of proportion of subjects with an anterior chamber cell (ACC) count of zero at day 7 and the proportion of subjects with a pain score of zero at day 1 did not show statistical significance, according to the Company.

The Company will continue to review the data to determine next steps for the development of EGP-437.

A phase III study of EGP-437 in anterior uveitis is underway, with data expected in the second quarter of 2018.

EYEG closed Monday's trading at $0.60, down 41.54%.

Prothena Corporation plc (PRTA) plunged nearly 19% on Monday, on news of resignation of Sarah Noonberg, the Company's Chief Medical Officer. She will provide Prothena with transitional support until March 15, 2018.

Near-term Catalysts:

-- Top-line results from a phase IIb study of NEOD001 in previously treated subjects with light chain (AL) Amyloidosis, dubbed PRONTO, are expected in the second quarter of 2018.
-- Clinical development of PRX004 for the treatment of ATTR amyloidosis is expected to begin around mid-2018.
-- A phase II study of PRX002/RG7935 for the treatment of Parkinson's disease, initiated in the second quarter of 2017, is underway.

PRTA closed Monday's trading at $32.14, down 18.84%.

Roche Group's (RHHBY) phase III study of TECENTRIQ and Avastin as a first-line treatment for advanced or metastatic renal cell carcinoma, dubbed IMmotion151, has yielded promising results.

According to the trial results, those who received TECENTRIQ plus Avastin had a 26-percent reduced risk of disease worsening or death (PFS) compared to people treated with Pfizer's Sutent.

IMmotion151 is the second phase III study to show positive PFS results for a treatment regimen including TECENTRIQ plus Avastin.

The first phase III study of TECENTRIQ plus Avastin, dubbed IMpower150, showed positive progression-free survival results in the initial treatment of people with advanced non-squamous non-small cell lung cancer.

RHHBY.OB closed Monday's trading at $29.20, down 2.67%.

Spectrum Pharmaceuticals Inc.'s (SPPI) first phase III study of Rolontis for chemotherapy-induced neutropenia, dubbed ADVANCE, has met the primary efficacy endpoint of non-inferiority in Duration of Severe Neutropenia between ROLONTIS and Amgen's Neulasta.

The positive top line data from the phase III study is an important milestone for Spectrum as we continue to move our Company forward, said Joe Turgeon, President and Chief Executive Officer.

The second phase III study of Rolontis for chemotherapy-induced neutropenia, dubbed RECOVER, is now fully enrolled.

The Company plans to file a Biologics License Application for Rolontis in the fourth quarter of this year.

SPPI closed Monday's trading at $20.57, unchanged from the previous day's close.

by RTT Staff Writer

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