Halozyme Therapeutics (HALO)

 

HYLENEX

 

Other manufacturers have FDA-approved products for use as spreading agents, including ISTA Pharmaceuticals, Inc., with an ovine (ram) hyaluronidase, Vitrase^®, Amphastar Pharmaceuticals, Inc., with a bovine hyaluronidase, Amphadase^tm, and Primapharm, Inc. also with a bovine hyaluronidase, Hydase^tm. In addition, some commercial pharmacies compound hyaluronidase preparations for institutions and physicians even though compounded preparations are not FDA-approved products. Some compounding pharmacies do not test every batch of product for drug concentration, sterility and lack of pyrogens. In addition, HYLENEX is priced at a significant premium compared to the animal-derived hyaluronidases currently in the marketplace. This price premium may slow market adoption of HYLENEX and make market penetration difficult.

 

Cumulase

 

A key clinical selling point for Cumulase is that it may eliminate the risk of animal pathogen transmission and toxicity inherent in slaughterhouse preparations. The competing enzymes are of animal origin, creating an opportunity for a recombinant human enzyme alternative. Cumulase is priced at a premium compared to the animal-derived products sold by these leading IVF suppliers, which may make market penetration difficult.

 

 

HYLENEX

 

Other manufacturers have FDA-approved products for use as spreading agents, including ISTA Pharmaceuticals, Inc., with an ovine (ram) hyaluronidase, Vitrase^®, Amphastar Pharmaceuticals, Inc., with a bovine hyaluronidase, Amphadase^tm, and Primapharm, Inc. also with a bovine hyaluronidase, Hydase^tm. In addition, some commercial pharmacies compound hyaluronidase preparations for institutions and physicians even though compounded preparations are not FDA-approved products. Some compounding pharmacies do not test every batch of product for drug concentration, sterility and lack of pyrogens. In addition, HYLENEX is priced at a significant premium compared to the animal-derived hyaluronidases currently in the marketplace. This price premium may slow market adoption of HYLENEX and make market penetration difficult.

 

Cumulase

 

A key clinical selling point for Cumulase is that it may eliminate the risk of animal pathogen transmission and toxicity inherent in slaughterhouse preparations. The competing enzymes are of animal origin, creating an opportunity for a recombinant human enzyme alternative. Cumulase is priced at a premium compared to the animal-derived products sold by these leading IVF suppliers, which may make market penetration difficult.

 

 

HYLENEX

 

Other manufacturers have FDA-approved products for use as
spreading agents, including ISTA Pharmaceuticals, Inc., with an
ovine (ram) hyaluronidase,
Vitrase^®,

Amphastar Pharmaceuticals, Inc., with a bovine hyaluronidase,
Amphadase^tm,

and Primapharm, Inc. also with a bovine hyaluronidase,
Hydase^tm.

In addition, some commercial pharmacies compound hyaluronidase
preparations for institutions and physicians even though
compounded preparations are not FDA-approved products. Some
compounding pharmacies do not test every batch of product for
drug concentration, sterility and lack of pyrogens. In addition,
HYLENEX is priced at a significant premium compared to the
animal-derived hyaluronidases currently in the marketplace. This
price premium may slow market adoption of HYLENEX and make
market penetration difficult.

 

Cumulase

 

A key clinical selling point for Cumulase is that it may
eliminate the risk of animal pathogen transmission and toxicity
inherent in slaughterhouse preparations. The competing enzymes
are of animal origin, creating an opportunity for a recombinant
human enzyme alternative. Cumulase is priced at a premium
compared to the animal-derived products sold by these leading
IVF suppliers, which may make market penetration difficult.

 

 

HYLENEX

 

Other manufacturers have FDA-approved products for use as
spreading agents, including ISTA Pharmaceuticals, Inc., with an
ovine (ram) hyaluronidase,
Vitrase^®,

Amphastar Pharmaceuticals, Inc., with a bovine hyaluronidase,
Amphadase^tm,

and Primapharm, Inc. also with a bovine hyaluronidase,
Hydase^tm.

In addition, some commercial pharmacies compound hyaluronidase
preparations for institutions and physicians even though
compounded preparations are not FDA-approved products. Some
compounding pharmacies do not test every batch of product for
drug concentration, sterility and lack of pyrogens. In addition,
HYLENEX is priced at a significant premium compared to the
animal-derived hyaluronidases currently in the marketplace. This
price premium may slow market adoption of HYLENEX and make
market penetration difficult.

 

Cumulase

 

A key clinical selling point for Cumulase is that it may
eliminate the risk of animal pathogen transmission and toxicity
inherent in slaughterhouse preparations. The competing enzymes
are of animal origin, creating an opportunity for a recombinant
human enzyme alternative. Cumulase is priced at a premium
compared to the animal-derived products sold by these leading
IVF suppliers, which may make market penetration difficult.

 

 

Cumulase

 

A key clinical selling point for Cumulase is that it may eliminate the risk of animal pathogen transmission and toxicity inherent in slaughterhouse preparations. The competing enzymes are of animal origin, creating an opportunity for us to enter the market with a recombinant human enzyme alternative. The leading IVF suppliers are CooperSurgical, Irvine Scientific, and Cook Ob/Gyn (all three of these companies produce bovine products) in the US, and MediCult (ovine product) and Vitrolife (bovine product) outside the US. Cumulase is priced at a premium compared to the animal-derived products sold by these leading IVF suppliers, which may make market penetration difficult.

 

Hylenex

 

Other manufacturers have FDA approved products for use as spreading agents, including ISTA Pharmaceuticals, Inc. (“ISTA”), with an ovine (ram) hyaluronidase, Vitrase^®, Amphastar Pharmaceuticals, Inc., with a bovine hyaluronidase, Amphadase^tm, and Primapharm, Inc. also with a bovine hyaluronidase, Hydase^tm. The FDA has determined that Amphadase, Hydase, Hylenex and Vitrase are distinct new chemical entities and hence afforded five years of market exclusivity. The five year market exclusivity precludes identical new chemical entity products from being marketed for a period of five years. As each of these products is established as distinctly different new chemical entities, the marketing exclusivity granted does not prohibit the marketing of the products. In addition, some commercial pharmacies now compound hyaluronidase preparations for institutions and physicians. However, there are some concerns with using a compounded sterile product. Compounded preparations are not FDA-approved products. Some compounding pharmacies do not test every batch of product for drug concentration, sterility, and lack of pyrogens. In addition, Hylenex is priced at a significant premium compared to the animal-derived hyaluronidases currently in the marketplace. This price premium may slow market adoption of Hylenex and make market penetration difficult.

 

Cumulase

 

A key clinical selling point for Cumulase is that it may eliminate the risk of animal pathogen transmission and toxicity inherent in slaughterhouse preparations. The competing enzymes are of animal origin, creating an opportunity for Halozyme to enter the market with a recombinant human enzyme alternative. The leading IVF suppliers are CooperSurgical, Irvine Scientific, and Cook Ob/Gyn (all three of these companies produce bovine products) in the US, and MediCult (ovine product) and Vitrolife (bovine product) outside the US. Cumulase is priced at a premium to the animal-derived products sold by these leading IVF suppliers, which may make market penetration difficult.

 

Hylenex

 

Other manufacturers have FDA approved products for use as spreading agents, including ISTA Pharmaceuticals, Inc. (“ISTA”), with an ovine (ram) hyaluronidase, Vitrase^®, Amphastar Pharmaceuticals, Inc., with a bovine (bull) hyaluronidase, Amphadase^tm, and Primapharm, Inc. also with a bovine hyaluronidase, Hydase^tm. The FDA has determined that Amphadase, Hydase, Hylenex and Vitrase are distinct new chemical entities and hence afforded five years of market exclusivity. The five year market exclusivity precludes identical new chemical entity products from being marketed for a period of five years. As each of these products are established as distinctly different new chemical entities the marketing exclusivity granted does not prohibit the marketing of the products. In addition, some commercial pharmacies now compound hyaluronidase preparations for institutions and physicians. However, there are some concerns with using a compounded sterile product. Compounded preparations are not FDA-approved products. Some compounding pharmacies do not test every batch of product for drug concentration, sterility, and lack of pyrogens. In addition, we anticipate that Hylenex will be priced at a significant premium to the animal-derived hyaluronidases currently in the marketplace. This anticipated price premium may slow market adoption of Hylenex and make market penetration difficult.