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Lannett Company, Inc.

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Lannett and Cediprof Announce Exclusive Distribution Agreement for An Approved Levothyroxine

Lead Product(s): Levothyroxine Sodium

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Cediprof

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement July 16, 2020

Details:

The companies have entered into an interim exclusive supply and distribution agreement for Cediprof's FDA approved Levothyroxine Sodium Tablets USP. Lannett to Commence Marketing on August 3, 2020.

Chiasma

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Camargo Client Chiasma Receives FDA Approval for Novel Somatostatin Analog for Long-Term Maintenance Treatment of Acromegaly

Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Product Name: Mycapssa

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 2020

Details:

Chiasma has obtained approval from the US Food and Drug Administration for MYCAPSSA® (octreotide) capsules. MYCAPSSA is the first and only oral somatostatin analog (SSA) approved by the FDA.

Chiasma

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Chiasma Announces Pricing of a Public Offering of $70 Million of Common Stock and Pre-Funded Warrants

Lead Product(s): Octreotide Acetate

Therapeutic Area: Endocrinology Product Name: Mycapssa

Highest Development Status: Approved Product Type: Peptide

Partner/Sponsor/Collaborator: Jefferies

Deal Size: $70.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering July 01, 2020

Details:

Chiasma intends to use the net proceeds from the offering primarily for advancing the ongoing commercialization of MYCAPSSA® in the United States for the treatment of acromegaly and for other pipeline activities.

Recordati Rare Diseases

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Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease

Lead Product(s): Osilodrostat

Therapeutic Area: Endocrinology Product Name: Isturisa

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 17, 2020

Details:

ISTURISA® (osilodrostat) demonstrates significant and sustained benefit over placebo at normalizing mean urinary free cortisol (mUFC) levels in patients with Cushing’s disease.

Merck & Co. Inc.

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Merck and Pfizer’s Steglatrotm Meets Primary Endpoint in VERTIS CV Trial for Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

Lead Product(s): Ertugliflozin

Therapeutic Area: Endocrinology Product Name: Steglatro

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 16, 2020

Details:

Phase 3 VERTIS CV cardiovascular outcomes trial evaluated STEGLATRO (ertugliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor, vs placebo, added to background standard of care treatment, in patients with type 2 diabetes and atherosclerotic CV disease.

Recordati Rare Diseases

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Recordati Rare Diseases Announces First European Launch of Isturisa® (osilodrostat)

Lead Product(s): Osilodrostat

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

Details:

Isturisa® (osilodrostat), a novel treatment for Cushing’s Syndrome, is now commercially available in France, and will be across select other European Union markets over 2020.

Aspargo Laboratories

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Aspargo Laboratories Announces Successful Completion of Pre-IND Meeting with FDA on Sildenafil Oral Spray to Treat Erectile Dysfunction

Lead Product(s): Sildenafil Citrate

Therapeutic Area: Endocrinology Product Name: Undisclosed

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 04, 2020

Details:

FDA supported Aspargo’s plan to conduct a single dose bioequivalent study to assess the pharmacokinetics, bioequivalency, tolerability and safety of the Company’s Sildenafil Oral Spray drug candidate.

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Companies

Lannett Company, Inc.

Lannett and Cediprof Announce Exclusive Distribution Agreement for An Approved Levothyroxine

Chiasma

Camargo Client Chiasma Receives FDA Approval for Novel Somatostatin Analog for Long-Term Maintenance Treatment of Acromegaly

Chiasma

Chiasma Announces Pricing of a Public Offering of $70 Million of Common Stock and Pre-Funded Warrants

Recordati Rare Diseases

Recordati Rare Diseases: Isturisa® (osilodrostat) Phase III LINC-4 Trial Meets Its Primary Endpoint in Cushing’s Disease

Merck & Co. Inc.

Merck and Pfizer’s Steglatrotm Meets Primary Endpoint in VERTIS CV Trial for Type 2 Diabetes and Atherosclerotic Cardiovascular Disease

Recordati Rare Diseases

Recordati Rare Diseases Announces First European Launch of Isturisa® (osilodrostat)

Aspargo Laboratories

Aspargo Laboratories Announces Successful Completion of Pre-IND Meeting with FDA on Sildenafil Oral Spray to Treat Erectile Dysfunction