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Company Directory

Use this alphabetized list to search for companies that provide information on single-patient expanded access. The web links in this directory are public information provided to the Foundation and the acknowledgement times listed are the number of days or hours for a company to acknowledge receipt of request, not to make a decision.

A |B |C |D |E |F |G |H |I |J |K |L |M |N |O |P |Q |R |S |T |U |V |W |X |Y |Z
Company Name
Phone Number & Email
Company Acknowledgement

AbbVie

Expected Application Timeframe
2 business days

Alexion

Expected Application Timeframe
3 business days

Alkermes

Expected Application Timeframe
2 weeks

Additional Information

Alnylam Pharmaceuticals

Phone Number & Email
Expected Application Timeframe
3 business days

Additional Information

Amgen

Expected Application Timeframe
3 business days

AMICUS THERAPEUTICS

Expected Application Timeframe
3 business days

Additional Information

SINGLE-PATIENT EA POLICIES/CRITERIA
Requests for Early Access cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver. Patients and caregivers seeking general information may reach out to Amicus’ Global Patient & Professional Advocacy Department at patientadvocacy@amicusrx.com or call toll-free in the United States at 1-866-9AMICUS (1-866-926-4287), or +44-1753-888-567 for International inquiries.

Astellas Pharma US

Expected Application Timeframe
7 days

AstraZeneca Pharmaceuticals LP

Expected Application Timeframe
Immediate

Bayer

Expected Application Timeframe
2 business days

Biogen

Expected Application Timeframe
1 business day

Boehringer Ingelheim Pharmaceuticals

Phone Number & Email
Expected Application Timeframe
5 business days

Bristol-Myers Squibb

Expected Application Timeframe
48 hours

Celgene

Phone Number & Email
Expected Application Timeframe
24 hours

Daiichi Sankyo

Expected Application Timeframe
10 business days

Eisai

Phone Number & Email
Expected Application Timeframe
2 business days

Eli Lilly

Phone Number & Email
Expected Application Timeframe
5 business days

EMD Serono

Expected Application Timeframe
5 business days

Genentech

Phone Number & Email
Expected Application Timeframe
3 business days

Additional Information

GlaxoSmithKline

Expected Application Timeframe
24 hours

Additional Information

SINGLE-PATIENT EA POLICIES/CRITERIA

http://www.gsk.com/media/3368/compassionate-use.pdf

Immix Biopharma

Phone Number & Email
Expected Application Timeframe
24hr to 48hr

Additional Information

Available therapies via single-patient EA

imx-110 - all advanced solid tumors

SINGLE-PATIENT EA POLICIES/CRITERIA

http://immixbio.com/pipeline/compassionate-use-policy/

Janssen

Expected Application Timeframe
Immediate

Additional Information

Johnson & Johnson

Lundbeck

Phone Number & Email
Expected Application Timeframe
10 business days

Merck & Co.

Phone Number & Email

Novartis Pharmaceuticals

Expected Application Timeframe
Immediately

Additional Information

Available therapies via single-patient EA
Alpelisib - Alpha-specific PI3K inhibitor
BGJ398 - Oral pan FGFR inhibitor
Buparlisib - Exploratory
Ceritinib - ALK+ treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that is ALK-positive
Dabrafenib - Combo Trametinib in Melanoma
Everolimus - mTOR inhibition in Exploratory Development & special project
Lapatinib - HER2+ breast cancer
Midostaurin - Hematologicial and Solid Cancers / Aggressive System
Nilotinib - CML
Panobinostat - Multiple Myeloma
Pasireotide - Exploratory/Tumor
Ribociclib - CDK4/6inhibitor
Ruxolitinib - Myelofibrosis
Tisagenlecleucel - CLL

Novo Nordisk

Expected Application Timeframe
5 business days

Oncoceutics, Inc.

Expected Application Timeframe
Receipt will generally be acknowledged within 48 hours

Additional Information

Available therapies via single-patient EA

ONC201 - H3 K27M mutant gliomas

SINGLE-PATIENT EA POLICIES/CRITERIA
Oncoceutics will consider single - patient expanded access for patients who meet the criteria for the company's existing expanded access program, as outlined on clinicaltrials.gov

Otsuka America Pharmaceutical

Expected Application Timeframe
1 week

Pfizer

Expected Application Timeframe
5 business days

Additional Information

SINGLE-PATIENT EA POLICIES/CRITERIA

www.pfizercares.com

Retrophin

Expected Application Timeframe
7 business days

Sanofi

Expected Application Timeframe
1 business day

SCYNEXIS, Inc.

Expected Application Timeframe
SCYNEXIS will acknowledge a contact for requesting Expanded Access within 24 hours.

Additional Information

Available therapies via single-patient EA
SCY-078 is a triterpenoid, glucan synthase inhibitor, antifungal agent undergoing investigation for:
• The treatment of invasive candidiasis, including candidemia (IC).
• The treatment of invasive aspergillosis (IA), including IA that is refractory to or intolerant of other antifungal therapies.
• The treatment of invasive candidiasis in patients who are refractory to or intolerant of other antifungal therapies.
SINGLE-PATIENT EA POLICIES/CRITERIA
SCYNEXIS is committed to making Investigational Products available to seriously ill patients who have exhausted other treatment options. A treating physician, who is able to comply with the SCYNEXIS requirements , may request information about how to apply for access to SCYNEXIS’ Investigational Products by contacting the company.

Shire

Expected Application Timeframe
3 business days

Takeda Pharmaceuticals

Expected Application Timeframe
3 business days

Teva

Expected Application Timeframe
1 business day

Additional Information

SINGLE-PATIENT EA POLICIES/CRITERIA

http://www.tevapharm.com/files/policy.pdf

UCB

Phone Number & Email

Additional Information

Ultragenyx

Additional Information

SINGLE-PATIENT EA POLICIES/CRITERIA
Requests for early access to investigational therapies must be made by a qualified physician.